Colony Laboratories, Inc.: FDA clearances and approvals
Colony Laboratories, Inc. has 16 FDA 510(k) clearances (first 1989, latest 1989), across 10 product codes in 1 review panel. Median 510(k) review time: 64 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 |
|---|---|---|---|
| DLJ | Calibrators, Drug Specific | 5 | 5 |
| DLG | Coating, Liquid, Glc | 3 | 3 |
| DLP | Radioimmunoassay, Diphenylhydantoin | 1 | 1 |
| KLQ | Radioimmunoassay, Amikacin | 1 | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 | 1 |
| KXT | Enzyme Immunoassay, Digoxin | 1 | 1 |
| LCQ | Fluorescent Immunoassay Gentamicin | 1 | 1 |
| LFW | Fluorescence Polarization Immunoassay, Tobramycin | 1 | 1 |
| LGQ | Fluorescence Polarization Immunoassay, Phenobarbital | 1 | 1 |
| LGS | Fluorescence Polarization Immunoassay, Theophylline | 1 | 1 |
Review panels
- Clinical Toxicology (16)
Most recent Colony Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K894524 | FPR GENTAMICIN CALIBRATOR KIT | DLG | 1989-09-28 | 70 |
| K894523 | FPR GENTAMICIN KIT | LCQ | 1989-09-28 | 70 |
| K894518 | FPR AMIKACIN CALIBRATOR KIT | DLG | 1989-09-28 | 70 |
| K894517 | FPR AMIKACIN KIT | KLQ | 1989-09-28 | 70 |
| K894528 | FPR PHENYTOIN CALIBRATOR KIT | DLG | 1989-09-25 | 67 |
| K894527 | FPR PHENYTOIN KIT | DLP | 1989-09-25 | 67 |
| K894522 | FPR DIGOXIN CALIBRATOR KIT | DLJ | 1989-09-25 | 67 |
| K894521 | FPR DIGOXIN KIT | KXT | 1989-09-25 | 67 |
| K894530 | FPR THEOPHYLLINE CALIBRATOR KIT | DLJ | 1989-09-18 | 60 |
| K894529 | FPR THEOPHYLLINE KIT | LGS | 1989-09-15 | 57 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Colony Laboratories, 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 Colony Laboratories, Inc. have?
Colony Laboratories, Inc. has 16 FDA 510(k) clearances (first 1989, latest 1989), across 10 product codes in 1 review panel.
How long does FDA take to clear Colony Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Colony Laboratories, Inc.'s cleared 510(k)s is 64 days.
What devices does Colony Laboratories, Inc. make?
Its most frequent FDA product codes are DLJ (Calibrators, Drug Specific, 5); DLG (Coating, Liquid, Glc, 3); DLP (Radioimmunoassay, Diphenylhydantoin, 1).
Has Colony Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Colony Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 16 Colony Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DLJ, Colony 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.