Columbia Bioscience, Inc.: FDA clearances and approvals
Columbia Bioscience, Inc. has 13 FDA 510(k) clearances (first 1996, latest 1999), across 7 product codes in 3 review panels. Median 510(k) review time: 129 days.
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 |
|---|---|---|---|
| LSE | Epstein-Barr Virus, Other | 3 | 3 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 | 2 |
| JZO | System, Test, Thyroid Autoantibody | 2 | 2 |
| LSR | Reagent, Borrelia Serological Reagent | 2 | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | 2 |
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | 1 |
| LYR | Helicobacter Pylori | 1 | 1 |
Review panels
- Microbiology (7)
- Immunology (4)
- Clinical Chemistry (2)
Most recent Columbia Bioscience, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991274 | MUMPS IGG ELISA TEST SYSTEM | LJY | 1999-09-03 | 143 |
| K990462 | IS H. PYLORI IGG ELISA TEST SYSTEM | LYR | 1999-09-03 | 203 |
| K984228 | IS ANTI-TPO IGG ELISA TEST SYSTEM | JZO | 1999-02-02 | 69 |
| K983606 | IS BORRELIA BURGDORFERI IGM TEST SYSTEM | LSR | 1998-12-16 | 63 |
| K983605 | IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | LSR | 1998-12-16 | 63 |
| K983553 | ANTI-TG IGG ELISA TEST SYSTEM | JZO | 1998-12-07 | 59 |
| K982352 | VCA IGM ELISA TEST SYSTEM | LSE | 1998-11-25 | 142 |
| K982350 | EA-D IGM ELISA TEST SYSTEM | LSE | 1998-11-25 | 142 |
| K982348 | EBNA-1 IGM ELISA TEST SYSTEM | LSE | 1998-11-25 | 142 |
| K983740 | IS-ANTI-PR3 IGG ELISA TEST SYSTEM | MOB | 1998-11-18 | 27 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Columbia Bioscience, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Columbia Bioscience, Inc. have?
Columbia Bioscience, Inc. has 13 FDA 510(k) clearances (first 1996, latest 1999), across 7 product codes in 3 review panels.
How long does FDA take to clear Columbia Bioscience, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Columbia Bioscience, Inc.'s cleared 510(k)s is 129 days.
What devices does Columbia Bioscience, Inc. make?
Its most frequent FDA product codes are LSE (Epstein-Barr Virus, Other, 3); JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 2); JZO (System, Test, Thyroid Autoantibody, 2).
Has Columbia Bioscience, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Columbia Bioscience, Inc. Related entities may recall under other names.
Next steps
- See all 13 Columbia Bioscience, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LSE, Columbia Bioscience, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.