The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Dri Cocaine Metabolite Assay.
| Device ID | K181499 |
| 510k Number | K181499 |
| Device Name: | DRI Cocaine Metabolite Assay |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | Microgenics Corporation 46500 Kato Road Fremont, CA 94538 |
| Contact | Emily Chien |
| Correspondent | Emily Chien Microgenics Corporation 46500 Kato Road Fremont, CA 94538 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-07 |
| Decision Date | 2018-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740165215 | K181499 | 000 |