Abbott Diagnostics Scarborough, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Abbott Diagnostics Scarborough, Inc.” (first 2019, latest 2026), plus 1 PMA decision, across 6 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 119 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 |
|---|---|---|
| 2019 | 1 | 31 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 98 |
| 2023 | 2 | 217 |
| 2024 | 0 | — |
| 2025 | 2 | 112 |
| 2026 | 1 | 28 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Abbott Diagnostics Scarborough, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 3 | 3 |
| NAH | System, Test, Tumor Marker, For Detection Of Bladder Cancer | 1 | 0 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | 1 | 1 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 1 | 1 |
| QWR | Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings | 1 | 1 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 1 | 1 |
Review panels
- Microbiology (7)
- Immunology (1)
Most recent Abbott Diagnostics Scarborough, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | OCC | 2026-08-31 | 28 |
| K250273 | BinaxNOW COVID-19 Ag Card | QVF | 2025-06-13 | 134 |
| K243518 | BinaxNOW COVID-19 Antigen Self Test | QYT | 2025-02-11 | 90 |
| K232775 | ID NOW Influenza A & B 2 | OCC | 2023-10-10 | 29 |
| K221925 | ID NOW COVID-19 2.0 | QWR | 2023-08-10 | 405 |
| K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | OZE | 2022-06-24 | 98 |
| K191534 | ID NOW Influenza A & B 2 | OCC | 2019-07-11 | 31 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P940035 | PMA | NMP22 BladderChek Test | 1996-07-02 |
Recalls
7 product recalls in 3 recall events; 7 initiated in the last five years. Most recent: 2026-02-09.
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 Molecular, Inc. (18 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abbott Diagnostics Scarborough, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Abbott Diagnostics Scarborough, Inc.” (first 2019, latest 2026), plus 1 PMA decision, across 6 product codes in 2 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 Diagnostics Scarborough, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott Diagnostics Scarborough, Inc. is 90 days. Since 2017: 90 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Abbott Diagnostics Scarborough, Inc.?
The most frequent FDA product codes under this applicant name are OCC (Respiratory Virus Panel Nucleic Acid Assay System, 3); NAH (System, Test, Tumor Marker, For Detection Of Bladder Cancer, 1); OZE (Influenza A And Influenza B Multiplex Nucleic Acid Assay, 1).
Next steps
- See all 7 Abbott Diagnostics Scarborough, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCC, Abbott Diagnostics Scarborough, 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.