Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Windsor Laboratories, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
85 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873281 | CARBAMAZEPINE (FPIA) CALIBRATOR KIT | Windsor Laboratories, Inc. | 1987-10-28 | 72 | 0 |
| K873282 | CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY | Windsor Laboratories, Inc. | 1987-09-22 | 36 | 0 |
| K871486 | (FPIA) ASSAY BUFFER | Windsor Laboratories, Inc. | 1987-05-08 | 23 | 0 |
| K870389 | DIGOXIN (FPIA) CALIBRATOR KIT | Windsor Laboratories, Inc. | 1987-04-01 | 61 | 0 |
| K870390 | PHENOBARBITAL (FPIA) CALIBRATOR KIT | Windsor Laboratories, Inc. | 1987-04-01 | 61 | 0 |
| K864333 | DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY | Windsor Laboratories, Inc. | 1987-01-05 | 62 | 0 |
| K863625 | PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT | Windsor Laboratories, Inc. | 1986-11-10 | 54 | 0 |
| K863244 | AMIKACIN (FPIA) CALIBRATOR KIT | Windsor Laboratories, Inc. | 1986-08-29 | 7 | 0 |
| K862248 | AMIKACIN KIT (FPIA) | Windsor Laboratories, Inc. | 1986-08-04 | 53 | 0 |
| K861769 | GENTAMICIN (FPIA) CALIBRATOR KIT | Windsor Laboratories, Inc. | 1986-06-25 | 49 | 0 |
| K861891 | TOBRAMYCIN (FPIA) CALIBRATOR KIT | Windsor Laboratories, Inc. | 1986-06-25 | 40 | 0 |
| K861770 | PHENYTOIN (FPIA) CALIBRATOR KIT | Windsor Laboratories, Inc. | 1986-06-25 | 49 | 0 |
| K861768 | THEOPHYLLINE (FPIA) CALIBRATOR KIT | Windsor Laboratories, Inc. | 1986-06-25 | 49 | 0 |
| K854392 | TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU | Windsor Laboratories, Inc. | 1985-12-05 | 35 | 0 |
| K852013 | GENTAMICIN KIT(FPIA) | Windsor Laboratories, Inc. | 1985-06-10 | 32 | 0 |
| K842585 | THEOPHYLLINE KIT FLUORESCENCE POLARIZA- | Windsor Laboratories, Inc. | 1984-09-26 | 85 | 0 |
| K842586 | PHENYTOIN KIT FLUORESCENCE POLARIZATION | Windsor Laboratories, Inc. | 1984-09-26 | 85 | 0 |
| K811442 | KWIK-LAC BETA-LACTAMASE KITS | Windsor Laboratories, Inc. | 1981-06-18 | 27 | 0 |
| K811412 | NEISSERIA-KWIK | Windsor Laboratories, Inc. | 1981-06-16 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda