K014192 is an FDA 510(k) clearance for the LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET. This device is classified as a Kit, Test, Multiple, Drugs Of Abuse, Over The Counter.
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on May 23, 2002, 153 days after receiving the submission on December 21, 2001.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K014192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2001 |
| Decision Date | May 23, 2002 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | MVO — Kit, Test, Multiple, Drugs Of Abuse, Over The Counter |
| Device Class | — |