Cooper Biomedical, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Cooper Biomedical, Inc.” (first 1983, latest 1987), across 18 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.
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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 1 | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 | 1 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 | 1 |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | 1 | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 | 1 |
| DEB | Alpha-2-Macroglobulin, Antigen, Antiserum, Control | 1 | 1 |
Plus 8 more product codes.
Review panels
- Immunology (9)
- Clinical Chemistry (7)
- Microbiology (2)
- Clinical Toxicology (1)
Most recent Cooper Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864512 | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO | DAD | 1987-02-13 | 92 |
| K863868 | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT | DFF | 1987-02-13 | 133 |
| K863301 | DEMAND TOTAL PROTEIN | CEK | 1986-09-26 | 32 |
| K861926 | WORTHINGTON HDL PRECIPITATING REAGENT SET | LBR | 1986-06-27 | 39 |
| K854130 | DEMAND ETHYL ALCOHOL | DIC | 1985-11-05 | 27 |
| K853949 | DEMAND ACID PHOSPHATASE REAGENT | CKB | 1985-10-16 | 22 |
| K852262 | ASSIST CLINICAL CHEMISTRY ANALYZER | JJE | 1985-06-25 | 32 |
| K851285 | RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI | DCF | 1985-06-17 | 77 |
| K851284 | RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM | CZP | 1985-06-11 | 71 |
| K851286 | RADIAL IMMUNODIFFUSION PLATES C3 & C4 | CZW | 1985-06-05 | 65 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cooper Biomedical, Inc..
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.
- Cooper Lasersonics, Inc. (54 510(k)s)
- Cooper Medical Devices Corp. (7 510(k)s)
- Cooper Surgical (6 510(k)s)
- Cooper Medical Corp. (5 510(k)s)
- Cooper Diagnostics, Inc. (1 510(k)s)
- Cooper Laboratories (1 510(k)s)
- Cooper Surgical/Aesthete (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cooper Biomedical, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Cooper Biomedical, Inc.” (first 1983, latest 1987), across 18 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 Cooper Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cooper Biomedical, Inc. is 52 days.
Which FDA product codes appear under Cooper Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, 2); CEK (Biuret (Colorimetric), Total Protein, 1); CKB (Acid Phosphatase, Naphthyl Phosphate, 1).
Next steps
- See all 19 Cooper Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJE, Cooper Biomedical, 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.