Tudor Laboratories, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Tudor Laboratories, Inc.” (first 1989, latest 1992), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 44 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 | 3 | 3 |
| JIS | Calibrator, Primary | 1 | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 | 1 |
| LAN | Enzyme Immunoassay, N-Acetylprocainamide | 1 | 1 |
| LEG | Enzyme Immunoassay, Valproic Acid | 1 | 1 |
| LFM | Enzyme Immunoassay, Digitoxin | 1 | 1 |
| LFT | Fluorescent Immunoassay, Primidone | 1 | 1 |
Review panels
Most recent Tudor Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921904 | THYROXINE (FPIA) KIT | KLI | 1992-06-24 | 64 |
| K921903 | THYROXINE CALIBRATOR KIT | JIS | 1992-05-26 | 35 |
| K913240 | DIGITOXIN (FPIA) KIT | LFM | 1991-09-06 | 46 |
| K895572 | N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT | DLJ | 1989-10-30 | 54 |
| K895571 | N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT | LAN | 1989-10-25 | 49 |
| K895567 | PRIMIDONE (FPIA) KIT | LFT | 1989-10-20 | 44 |
| K895569 | VALPROIC ACID (FPIA) KIT | LEG | 1989-10-03 | 27 |
| K895570 | VALPROIC ACID (FPIA) CALIBRATOR KIT | DLJ | 1989-09-28 | 22 |
| K895568 | PRIMIDONE (FPIA) CALIBRATOR KIT | DLJ | 1989-09-28 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Tudor 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tudor Laboratories, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Tudor Laboratories, Inc.” (first 1989, latest 1992), across 7 product codes in 2 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 Tudor Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tudor Laboratories, Inc. is 44 days.
Which FDA product codes appear under Tudor Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are DLJ (Calibrators, Drug Specific, 3); JIS (Calibrator, Primary, 1); KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, 1).
Next steps
- See all 9 Tudor Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DLJ, Tudor 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.