The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Qms Carbamazepine Assay.
| Device ID | K940374 |
| 510k Number | K940374 |
| Device Name: | QMS CARBAMAZEPINE ASSAY |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Andris Indriksons, Ph.d. |
| Correspondent | Andris Indriksons, Ph.d. SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-26 |
| Decision Date | 1994-06-02 |