The following data is part of a premarket notification filed by Innotron Of Oregon, Inc. with the FDA for Innofluor Carbamazepine Reagent Set.
| Device ID | K893507 |
| 510k Number | K893507 |
| Device Name: | INNOFLUOR CARBAMAZEPINE REAGENT SET |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland, OR 97202 |
| Contact | Janelle Batley |
| Correspondent | Janelle Batley INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland, OR 97202 |
| Product Code | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-05 |
| Decision Date | 1989-08-11 |