The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Dridau Opiate Assay.
| Device ID | K011150 |
| 510k Number | K011150 |
| Device Name: | DRIDAU OPIATE ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-16 |
| Decision Date | 2001-06-20 |