K043167 is an FDA 510(k) clearance for the PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X. This device is classified as a Enzyme Immunoassay, Benzodiazepine (Class II - Special Controls, product code JXM).
Submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 29, 2004, 43 days after receiving the submission on November 16, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3170.
| 510(k) Number | K043167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2004 |
| Decision Date | December 29, 2004 |
| Days to Decision | 43 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JXM — Enzyme Immunoassay, Benzodiazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3170 |