The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Buprenorphine Assay.
| Device ID | K040316 |
| 510k Number | K040316 |
| Device Name: | CEDIA BUPRENORPHINE ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | David Casal |
| Correspondent | David Casal MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | DJG |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-09 |
| Decision Date | 2004-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883011670 | K040316 | 000 |
| 00884883001756 | K040316 | 000 |
| 00884883001749 | K040316 | 000 |
| 00884883001732 | K040316 | 000 |
| 00884883001725 | K040316 | 000 |
| 00884883001718 | K040316 | 000 |
| 00884883001701 | K040316 | 000 |
| 00884883001695 | K040316 | 000 |
| 00884883001602 | K040316 | 000 |