K231007 is an FDA 510(k) clearance for the CEDIA Heroin Metabolite (6-AM) Assay. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Microgenics Corporation (Fremont, US). The FDA issued a Cleared decision on September 27, 2023, 173 days after receiving the submission on April 7, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K231007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2023 |
| Decision Date | September 27, 2023 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |