The following data is part of a premarket notification filed by Ucp Biosciences, Inc. with the FDA for Ucp Rapid Drug Screening Buprenorphine, Amp 300, Mamp 500, Coc 150 Test;.
| Device ID | K091612 |
| 510k Number | K091612 |
| Device Name: | UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | UCP BIOSCIENCES, INC. 1445 KOLL CIRCLE, STE. 111 San Jose, CA 95112 |
| Contact | Nancy Chen |
| Correspondent | Nancy Chen UCP BIOSCIENCES, INC. 1445 KOLL CIRCLE, STE. 111 San Jose, CA 95112 |
| Product Code | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LAF |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-03 |
| Decision Date | 2010-02-24 |
| Summary: | summary |