K151441 is an FDA 510(k) clearance for the First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test. This device is classified as a Enzyme Immunoassay, Methadone (Class II - Special Controls, product code DJR).
Submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on June 29, 2015, 31 days after receiving the submission on May 29, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3620.
| 510(k) Number | K151441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2015 |
| Decision Date | June 29, 2015 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DJR - Enzyme Immunoassay, Methadone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3620 |