K050465 is an FDA 510(k) clearance for the IMMUNALYSIS COCAINE ELISA FOR HAIR. This device is classified as a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II - Special Controls, product code DIO).
Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on August 4, 2005, 154 days after receiving the submission on March 3, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K050465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2005 |
| Decision Date | August 04, 2005 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3250 |