K052197 is an FDA 510(k) clearance for the FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST. This device is classified as a Enzyme Immunoassay, Methadone (Class II - Special Controls, product code DJR).
Submitted by W.H.P.M., Inc. (Beverly, US). The FDA issued a Cleared decision on June 9, 2006, 301 days after receiving the submission on August 12, 2005.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3620.
| 510(k) Number | K052197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2005 |
| Decision Date | June 09, 2006 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJR - Enzyme Immunoassay, Methadone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3620 |