K050945 is an FDA 510(k) clearance for the ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, 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. (Synnyvale, US). The FDA issued a Cleared decision on March 29, 2006, 349 days after receiving the submission on April 14, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K050945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2005 |
| Decision Date | March 29, 2006 |
| Days to Decision | 349 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 |