The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Dau Amphassure Assay.
| Device ID | K994380 |
| 510k Number | K994380 |
| Device Name: | CEDIA DAU AMPHASSURE ASSAY |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Neal Bellet |
| Correspondent | Neal Bellet MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-27 |
| Decision Date | 2000-05-02 |
| Summary: | summary |