The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Cedia Heroin Metabolite (6-am) Assay.
| Device ID | K192943 |
| 510k Number | K192943 |
| Device Name: | CEDIA Heroin Metabolite (6-AM) Assay |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Microgenics Corporation 46500 Kato Road Fremont, CA 94538 |
| Contact | Sharron Penn |
| Correspondent | Sharron Penn Microgenics Corporation 46500 Kato Road 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 | 2019-10-18 |
| Decision Date | 2019-12-16 |