The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Dau Cocaine Assay.
| Device ID | K941310 |
| 510k Number | K941310 |
| Device Name: | CEDIA DAU COCAINE ASSAY |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | MICROGENICS CORP. 2400 BISSO LN. Concord, CA 94520 |
| Contact | Patricia Klimley |
| Correspondent | Patricia Klimley MICROGENICS CORP. 2400 BISSO LN. Concord, CA 94520 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-14 |
| Decision Date | 1994-06-02 |