K110515 is an FDA 510(k) clearance for the UCP DRUG SCREENING TEST CUPS. This device is classified as a Enzyme Immunoassay, Barbiturate (Class II - Special Controls, product code DIS).
Submitted by Ucp Biosciences, Inc. (San Jose, US). The FDA issued a Cleared decision on April 20, 2011, 56 days after receiving the submission on February 23, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K110515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2011 |
| Decision Date | April 20, 2011 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DIS — Enzyme Immunoassay, Barbiturate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3150 |