The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia(r) Carbamazepine Assay.
| Device ID | K914857 |
| 510k Number | K914857 |
| Device Name: | CEDIA(R) CARBAMAZEPINE ASSAY |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Patricia M Klimley |
| Correspondent | Patricia M Klimley MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-29 |
| Decision Date | 1992-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883001251 | K914857 | 000 |