Company ยท US
Colony Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1989. Name variants (Inc, Corp, punctuation) are merged.
16510(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 | 5 |
| DLG | Coating, Liquid, Glc | 3 |
| DLP | Radioimmunoassay, Diphenylhydantoin | 1 |
| KLQ | Radioimmunoassay, Amikacin | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 |
| KXT | Enzyme Immunoassay, Digoxin | 1 |
| LCQ | Fluorescent Immunoassay Gentamicin | 1 |
| LFW | Fluorescence Polarization Immunoassay, Tobramycin | 1 |
| LGQ | Fluorescence Polarization Immunoassay, Phenobarbital | 1 |
| LGS | Fluorescence Polarization Immunoassay, Theophylline | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 28, 1989 | K894524 | FPR GENTAMICIN CALIBRATOR KIT Colony Laboratories, Inc. | DLG |
| Sep 28, 1989 | K894523 | FPR GENTAMICIN KIT Colony Laboratories, Inc. | LCQ |
| Sep 28, 1989 | K894518 | FPR AMIKACIN CALIBRATOR KIT Colony Laboratories, Inc. | DLG |
| Sep 28, 1989 | K894517 | FPR AMIKACIN KIT Colony Laboratories, Inc. | KLQ |
| Sep 25, 1989 | K894528 | FPR PHENYTOIN CALIBRATOR KIT Colony Laboratories, Inc. | DLG |
| Sep 25, 1989 | K894527 | FPR PHENYTOIN KIT Colony Laboratories, Inc. | DLP |
| Sep 25, 1989 | K894522 | FPR DIGOXIN CALIBRATOR KIT Colony Laboratories, Inc. | DLJ |
| Sep 25, 1989 | K894521 | FPR DIGOXIN KIT Colony Laboratories, Inc. | KXT |
| Sep 18, 1989 | K894530 | FPR THEOPHYLLINE CALIBRATOR KIT Colony Laboratories, Inc. | DLJ |
| Sep 15, 1989 | K894529 | FPR THEOPHYLLINE KIT Colony Laboratories, Inc. | LGS |
| Sep 1, 1989 | K894532 | FPR TOBRAMYCIN CALIBRATOR KIT Colony Laboratories, Inc. | DLJ |
| Sep 1, 1989 | K894531 | FPR TOBRAMYCIN KIT Colony Laboratories, Inc. | LFW |
| Aug 28, 1989 | K894526 | FPR PHENOBARBITAL CALIBRATOR KIT Colony Laboratories, Inc. | DLJ |
| Aug 28, 1989 | K894525 | FPR PHENOBARBITAL KIT Colony Laboratories, Inc. | LGQ |
| Aug 28, 1989 | K894520 | FPR CARBAMAZEPINE CALIBRATOR KIT Colony Laboratories, Inc. | DLJ |
| Aug 28, 1989 | K894519 | FPR CARBAMAZEPINE KIT Colony Laboratories, Inc. | KLT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||