K010833 is an FDA 510(k) clearance for the AT WORK DRUG TEST, MODEL 9177T AWT. This device is classified as a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II - Special Controls, product code DIO).
Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on April 11, 2001, 22 days after receiving the submission on March 20, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K010833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2001 |
| Decision Date | April 11, 2001 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3250 |