The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Dau 6-acetylmorphine Assay.
| Device ID | K001178 |
| 510k Number | K001178 |
| Device Name: | CEDIA DAU 6-ACETYLMORPHINE ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Cynthia Merrell |
| Correspondent | Cynthia Merrell MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | DJG |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-11 |
| Decision Date | 2000-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883001343 | K001178 | 000 |
| 00884883001336 | K001178 | 000 |