Windsor Laboratories, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Windsor Laboratories, Inc.” (first 1981, latest 1987), across 13 product codes in 3 review panels. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| 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 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.
- Windsor Medical, Inc. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Windsor Laboratories, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Windsor Laboratories, Inc.” (first 1981, latest 1987), across 13 product codes in 3 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 Windsor Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Windsor Laboratories, Inc. is 49 days.
Which FDA product codes appear under Windsor Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are DLJ (Calibrators, Drug Specific, 4); JIS (Calibrator, Primary, 4); JJF (Analyzer, Chemistry, Micro, For Clinical Use, 1).
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. 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.