K060810 is an FDA 510(k) clearance for the ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Ind Diagnostic, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on August 7, 2006, 136 days after receiving the submission on March 24, 2006.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K060810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2006 |
| Decision Date | August 07, 2006 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |