The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia(r) Dau Opiate Assay.
| Device ID | K935346 |
| 510k Number | K935346 |
| Device Name: | CEDIA(R) DAU OPIATE ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Betsy Soares-maddox |
| Correspondent | Betsy Soares-maddox MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-05 |
| Decision Date | 1994-01-11 |