Abbott Diagnostics: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Abbott Diagnostics” (first 1981, latest 1997), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 52 days. 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 7 | 7 |
| GKZ | Counter, Differential Cell | 6 | 6 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 3 | 3 |
| GIF | Diluent, Blood Cell | 2 | 2 |
| GKH | Apparatus, Automated Blood Cell Diluting | 2 | 2 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| GGK | Products, Red-Cell Lysing Products | 1 | 1 |
| GJZ | Cyanomethemoglobin Reagent And Standard Solution | 1 | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 | 1 |
| JPK | Mixture, Hematology Quality Control | 1 | 1 |
Plus 3 more product codes.
Review panels
- Hematology (20)
- Clinical Chemistry (6)
- Immunology (1)
- Microbiology (1)
Most recent Abbott Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964185 | IMX CA 125 | LTK | 1997-11-04 | 379 |
| K972182 | ABBOTT STREP A CONTROLS | MJZ | 1997-08-13 | 76 |
| K961439 | ABBOTT CELL-DYN 4000 SYSTEM | GKZ | 1996-10-18 | 186 |
| K890491 | CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER | GKZ | 1989-04-18 | 77 |
| K881242 | CELL-DYN RAPID-LYSE AND HEMOGLOBLIN | GJZ | 1988-04-21 | 36 |
| K881130 | CELL-DYN ISOTONIC DILUENT | GIF | 1988-03-31 | 15 |
| K873348 | CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. | GGK | 1987-09-09 | 20 |
| K873347 | CELL-DYN DIFF. SCREEN ISOTONIC DILUENT | GIF | 1987-09-09 | 20 |
| K873408 | MODEL 690 SPECTROPHOTOMETER | JJQ | 1987-09-08 | 14 |
| K872761 | CELL-DYN 610 HEMATOLOGY ANALYZER | GKZ | 1987-08-06 | 24 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Abbott Diagnostics.
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 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)
- Abbott Diagnostics Scarborough, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abbott Diagnostics?
FDA lists 28 510(k) clearances under the applicant name “Abbott Diagnostics” (first 1981, latest 1997), across 13 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 Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott Diagnostics is 52 days.
Which FDA product codes appear under Abbott Diagnostics?
The most frequent FDA product codes under this applicant name are GKL (Counter, Cell, Automated (Particle Counter), 7); GKZ (Counter, Differential Cell, 6); JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 3).
Next steps
- See all 28 Abbott Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code GKL, Abbott Diagnostics'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.