K113139 is an FDA 510(k) clearance for the LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS. This device is classified as a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II - Special Controls, product code DIO).
Submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 22, 2011, 29 days after receiving the submission on October 24, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K113139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2011 |
| Decision Date | November 22, 2011 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3250 |