K163101 is an FDA 510(k) clearance for the CEDIA Buprenorphine II 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 April 6, 2017, 150 days after receiving the submission on November 7, 2016.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K163101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2016 |
| Decision Date | April 06, 2017 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |