Windsor Laboratories, Inc.: FDA clearances and approvals
Windsor Laboratories, Inc. has 19 FDA 510(k) clearances (first 1981, latest 1987), across 13 product codes in 3 review panels. Median 510(k) review time: 49 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 | 4 | 4 |
| JIS | Calibrator, Primary | 4 | 4 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | 1 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 | 1 |
| KXT | Enzyme Immunoassay, Digoxin | 1 | 1 |
| LCQ | Fluorescent Immunoassay Gentamicin | 1 | 1 |
| LER | Fluorescent Immunoassay, Theophylline | 1 | 1 |
| LFW | Fluorescence Polarization Immunoassay, Tobramycin | 1 | 1 |
| LGJ | Fluorescence Polarization Immunoassay, Amibacin | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Toxicology (12)
- Clinical Chemistry (5)
- Microbiology (1)
Most recent Windsor Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873281 | CARBAMAZEPINE (FPIA) CALIBRATOR KIT | DLJ | 1987-10-28 | 72 |
| K873282 | CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY | KLT | 1987-09-22 | 36 |
| K871486 | (FPIA) ASSAY BUFFER | JJF | 1987-05-08 | 23 |
| K870390 | PHENOBARBITAL (FPIA) CALIBRATOR KIT | DLJ | 1987-04-01 | 61 |
| K870389 | DIGOXIN (FPIA) CALIBRATOR KIT | DLJ | 1987-04-01 | 61 |
| K864333 | DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY | KXT | 1987-01-05 | 62 |
| K863625 | PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT | LGQ | 1986-11-10 | 54 |
| K863244 | AMIKACIN (FPIA) CALIBRATOR KIT | DLJ | 1986-08-29 | 7 |
| K862248 | AMIKACIN KIT (FPIA) | LGJ | 1986-08-04 | 53 |
| K861891 | TOBRAMYCIN (FPIA) CALIBRATOR KIT | JIS | 1986-06-25 | 40 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Windsor 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 Windsor Laboratories, Inc. have?
Windsor Laboratories, Inc. has 19 FDA 510(k) clearances (first 1981, latest 1987), across 13 product codes in 3 review panels.
How long does FDA take to clear Windsor Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Windsor Laboratories, Inc.'s cleared 510(k)s is 49 days.
What devices does Windsor Laboratories, Inc. make?
Its most frequent FDA product codes are DLJ (Calibrators, Drug Specific, 4); JIS (Calibrator, Primary, 4); JJF (Analyzer, Chemistry, Micro, For Clinical Use, 1).
Has Windsor Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Windsor Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 19 Windsor Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DLJ, Windsor 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.