The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Carbamazepine Eia Test.
| Device ID | K955100 |
| 510k Number | K955100 |
| Device Name: | CARBAMAZEPINE EIA TEST |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Contact | Yuh-geng Tsay |
| Correspondent | Yuh-geng Tsay DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Product Code | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-08 |
| Decision Date | 1995-12-13 |