The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Dri Benzodiazepine Assay.
| Device ID | K173963 |
| 510k Number | K173963 |
| Device Name: | DRI Benzodiazepine Assay |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | Microgenics Corporation 46500 Kato Road Fremont, CA 94538 |
| Contact | Minoti Patel |
| Correspondent | Minoti Patel Microgenics Corporation 46500 Kato Road Fremont, CA 94538 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-28 |
| Decision Date | 2018-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883011649 | K173963 | 000 |
| 00380740165185 | K173963 | 000 |