Clark Laboratories, Inc.: FDA clearances and approvals
Clark Laboratories, Inc. has 14 FDA 510(k) clearances (first 1992, latest 1998), across 8 product codes in 2 review panels. Median 510(k) review time: 152 days. openFDA lists 2 product recalls by a recalling firm named Clark Laboratories, Inc.
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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 5 | 5 |
| LSE | Epstein-Barr Virus, Other | 3 | 3 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 | 1 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 | 1 |
Review panels
- Immunology (9)
- Microbiology (5)
Most recent Clark Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980912 | VCA IGG ELISA TEST SYSTEM | LSE | 1998-07-22 | 134 |
| K980596 | VCA IGM ELISA TEST SYSTEM | LSE | 1998-07-22 | 155 |
| K980598 | EBNA-1 IGM ELISA TEST SYSTEM | LLM | 1998-05-01 | 73 |
| K973123 | EA-D IGG ELISA TEST SYSTEM | LSE | 1998-03-26 | 218 |
| K931543 | ENCORE ENA COMBINED EIA | LLL | 1993-09-08 | 163 |
| K925826 | ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA | JZO | 1993-01-26 | 71 |
| K923537 | ENCORE DS-DNA | LRM | 1992-12-23 | 160 |
| K921870 | ENCORE SM/RNP | LLL | 1992-12-01 | 225 |
| K921572 | ENCORE SM | LLL | 1992-12-01 | 243 |
| K922340 | ENCORE SS-B | LLL | 1992-10-16 | 150 |
4 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2021-10-11.
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 Clark Laboratories, Inc. have?
Clark Laboratories, Inc. has 14 FDA 510(k) clearances (first 1992, latest 1998), across 8 product codes in 2 review panels.
How long does FDA take to clear Clark Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Clark Laboratories, Inc.'s cleared 510(k)s is 152 days.
What devices does Clark Laboratories, Inc. make?
Its most frequent FDA product codes are LLL (Extractable Antinuclear Antibody, Antigen And Control, 5); LSE (Epstein-Barr Virus, Other, 3); DHR (System, Test, Rheumatoid Factor, 1).
Has Clark Laboratories, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Clark Laboratories, Inc; the most recent began 2021-10-11. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 14 Clark Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLL, Clark Laboratories, 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.