The following data is part of a premarket notification filed by Innotron Of Oregon, Inc. with the FDA for Modified Accufluor Carbamazepine Reagent & Calibra.
| Device ID | K900702 |
| 510k Number | K900702 |
| Device Name: | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA |
| Classification | Fluorescence Polarization Immunoassay, Carbamazepine |
| Applicant | INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland, OR 97202 |
| Contact | Craig Smart |
| Correspondent | Craig Smart INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland, OR 97202 |
| Product Code | LGI |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-12 |
| Decision Date | 1990-04-12 |