Abbott Molecular, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Abbott Molecular, Inc.” (first 2008, latest 2025), plus 14 PMA and 1 De Novo decisions, across 25 product codes in 4 review panels. Median 510(k) review time under this name: 246 days. Since 2017 the median was 235 days, against 176 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Abbott, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 112 |
| 2014 | 1 | 86 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 446 |
| 2023 | 1 | 210 |
| 2024 | 2 | 202 |
| 2025 | 6 | 246 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Abbott Molecular, Inc. took a median 235 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 176 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | 3 | 1 |
| PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | 3 | 1 |
| MKT | Hepatitis Viral B Dna Detection | 2 | 0 |
| OWD | Somatic Gene Mutation Detection System | 2 | 0 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 2 | 2 |
| QLX | Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna | 2 | 2 |
| LSK | Dna-Reagents, Chlamydia | 1 | 1 |
| LSL | Dna-Reagents, Neisseria | 1 | 1 |
| MAQ | Kit, Dna Detection, Human Papillomavirus | 1 | 0 |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | 1 | 1 |
Plus 15 more product codes.
Review panels
- Microbiology (22)
- Pathology (8)
- Clinical Chemistry (1)
- Medical Genetics (1)
Most recent Abbott Molecular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252102 | Alinity m HCV | MZP | 2025-09-25 | 84 |
| K243489 | Alinity m EBV (09N43-095) | QLX | 2025-07-28 | 258 |
| K243485 | Alinity m CMV | PAB | 2025-07-01 | 235 |
| K241921 | Alinity m BKV | QMI | 2025-03-24 | 266 |
| K241573 | Alinity m Resp-4-Plex | QOF | 2025-02-14 | 256 |
| K243410 | simpli-COLLECT STI Test | QYA | 2025-01-30 | 90 |
| K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) | QQX | 2024-12-06 | 186 |
| K233349 | Alinity m HSV 1 & 2 / VZV | PGI | 2024-05-03 | 217 |
| K222379 | Alinity m STI Assay | QEP | 2023-03-03 | 210 |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) | QLX | 2022-07-15 | 317 |
8 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230003 | PMA | Alinity m HR HPV | 2023-11-01 |
| P210022 | PMA | Alinity m CMV | 2022-05-05 |
| P200013 | PMA | Alinity m HBV | 2020-08-29 |
| P190025 | PMA | Alinity m HCV | 2020-03-23 |
| P170041 | PMA | Abbott RealTime IDH1 | 2018-07-20 |
Recalls
47 product recalls in 34 recall events; 24 initiated in the last five years. Most recent: 2025-04-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Abbott Laboratories (889 510(k)s)
- ABBOTT MEDICAL (60 510(k)s)
- Abbott Vascular (50 510(k)s)
- Abbott Diabetes Care, Inc. (39 510(k)s)
- Abbott Diagnostics (28 510(k)s)
- Abbott Point of Care, Inc. (22 510(k)s)
- Abbott Mfg., Inc. (14 510(k)s)
- Abbott Medical Optics, Inc. (13 510(k)s)
- Abbott (13 510(k)s)
- Abbott Spine, Inc. (13 510(k)s)
- Abbott Ireland Diagnostics Division (8 510(k)s)
- Abbott Diagnostics Scarborough, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abbott Molecular, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Abbott Molecular, Inc.” (first 2008, latest 2025), plus 14 PMA and 1 De Novo decisions, across 25 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Abbott Molecular, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott Molecular, Inc. is 246 days. Since 2017: 235 days, versus 176 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Abbott Molecular, Inc.?
The most frequent FDA product codes under this applicant name are MZP (Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus, 3); PAB (Cytomegalovirus (Cmv) Dna Quantitative Assay, 3); MKT (Hepatitis Viral B Dna Detection, 2).
Next steps
- See all 18 Abbott Molecular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MZP, Abbott Molecular, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.