The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Dri Ecstasy Enzyme Immunoassay.
| Device ID | K012110 |
| 510k Number | K012110 |
| Device Name: | DRI ECSTASY ENZYME IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Sherrie Rinne |
| Correspondent | Sherrie Rinne 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 | 2001-07-06 |
| Decision Date | 2001-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883011342 | K012110 | 000 |
| 00884883006751 | K012110 | 000 |
| 00884883002883 | K012110 | 000 |
| 00884883001350 | K012110 | 000 |
| 00380740165222 | K012110 | 000 |