The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Abbott Carbamazepine Assay.
| Device ID | K123518 |
| 510k Number | K123518 |
| Device Name: | ABBOTT CARBAMAZEPINE ASSAY |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | Microgenics Corporation 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Karen Lee |
| Correspondent | Karen Lee Microgenics Corporation 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-14 |
| Decision Date | 2013-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740102685 | K123518 | 000 |
| 00380740135331 | K123518 | 000 |