K994164 is an FDA 510(k) clearance for the ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 13, 2000, 126 days after receiving the submission on December 9, 1999.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K994164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1999 |
| Decision Date | April 13, 2000 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |