K101195 is an FDA 510(k) clearance for the 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 6, 2010, 68 days after receiving the submission on April 29, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K101195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2010 |
| Decision Date | July 06, 2010 |
| Days to Decision | 68 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 |