K122419 is an FDA 510(k) clearance for the UCP HOME DRUG SCREENING TEST CUPS. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Ucp Biosciences, Inc. (San Jose, US). The FDA issued a Cleared decision on November 30, 2012, 113 days after receiving the submission on August 9, 2012.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K122419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2012 |
| Decision Date | November 30, 2012 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |