The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Dri Hydrocodone Assay, Dri Hydrocodone Calibrators, Dri Hydrocodone Controls.
| Device ID | K150502 |
| 510k Number | K150502 |
| Device Name: | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Microgenics Corporation 46500 Kato Road Fremont, CA 94538 |
| Contact | Tammy Wharton |
| Correspondent | Laurie Wong Microgenics Corporation 46500 Kato Road Fremont, CA 94538 |
| Product Code | DJG |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-26 |
| Decision Date | 2015-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883000407 | K150502 | 000 |
| 00884883000391 | K150502 | 000 |
| 00884883000384 | K150502 | 000 |
| 00884883000377 | K150502 | 000 |
| 00884883000360 | K150502 | 000 |