Company ยท US
Windsor Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1987. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DLJ | Calibrators, Drug Specific | 4 |
| JIS | Calibrator, Primary | 4 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 |
| KXT | Enzyme Immunoassay, Digoxin | 1 |
| LCQ | Fluorescent Immunoassay Gentamicin | 1 |
| LER | Fluorescent Immunoassay, Theophylline | 1 |
| LFW | Fluorescence Polarization Immunoassay, Tobramycin | 1 |
| LGJ | Fluorescence Polarization Immunoassay, Amibacin | 1 |
| LGQ | Fluorescence Polarization Immunoassay, Phenobarbital | 1 |
| LGR | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 28, 1987 | K873281 | CARBAMAZEPINE (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. | DLJ |
| Sep 22, 1987 | K873282 | CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY Windsor Laboratories, Inc. | KLT |
| May 8, 1987 | K871486 | (FPIA) ASSAY BUFFER Windsor Laboratories, Inc. | JJF |
| Apr 1, 1987 | K870390 | PHENOBARBITAL (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. | DLJ |
| Apr 1, 1987 | K870389 | DIGOXIN (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. | DLJ |
| Jan 5, 1987 | K864333 | DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY Windsor Laboratories, Inc. | KXT |
| Nov 10, 1986 | K863625 | PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT Windsor Laboratories, Inc. | LGQ |
| Aug 29, 1986 | K863244 | AMIKACIN (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. | DLJ |
| Aug 4, 1986 | K862248 | AMIKACIN KIT (FPIA) Windsor Laboratories, Inc. | LGJ |
| Jun 25, 1986 | K861891 | TOBRAMYCIN (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. | JIS |
| Jun 25, 1986 | K861770 | PHENYTOIN (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. | JIS |
| Jun 25, 1986 | K861769 | GENTAMICIN (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. | JIS |
| Jun 25, 1986 | K861768 | THEOPHYLLINE (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. | JIS |
| Dec 5, 1985 | K854392 | TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU Windsor Laboratories, Inc. | LFW |
| Jun 10, 1985 | K852013 | GENTAMICIN KIT(FPIA) Windsor Laboratories, Inc. | LCQ |
| Sep 26, 1984 | K842586 | PHENYTOIN KIT FLUORESCENCE POLARIZATION Windsor Laboratories, Inc. | LGR |
| Sep 26, 1984 | K842585 | THEOPHYLLINE KIT FLUORESCENCE POLARIZA- Windsor Laboratories, Inc. | LER |
| Jun 18, 1981 | K811442 | KWIK-LAC BETA-LACTAMASE KITS Windsor Laboratories, Inc. | |
| Jun 16, 1981 | K811412 | NEISSERIA-KWIK Windsor Laboratories, Inc. | JSX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||