K062565 is an FDA 510(k) clearance for the STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE. This device is classified as a Enzyme Immunoassay, Nicotine And Nicotine Metabolites (Class I - General Controls, product code MKU).
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on February 20, 2007, 173 days after receiving the submission on August 31, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3220.
| 510(k) Number | K062565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2006 |
| Decision Date | February 20, 2007 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MKU — Enzyme Immunoassay, Nicotine And Nicotine Metabolites |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3220 |