The following data is part of a premarket notification filed by Colony Laboratories, Inc. with the FDA for Fpr Carbamazepine Kit.
| Device ID | K894519 |
| 510k Number | K894519 |
| Device Name: | FPR CARBAMAZEPINE KIT |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | COLONY LABORATORIES, INC. 1220 NINETEENTH STREET, N.W. FOURTH FLOOR Washington, DC 20036 |
| Contact | Dale B Hinson |
| Correspondent | Dale B Hinson COLONY LABORATORIES, INC. 1220 NINETEENTH STREET, N.W. FOURTH FLOOR Washington, DC 20036 |
| Product Code | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-08-28 |