The following data is part of a premarket notification filed by Ucp Biosciences, Inc. with the FDA for Ucp Multi-drug Test Key Cups.
| Device ID | K132812 |
| 510k Number | K132812 |
| Device Name: | UCP MULTI-DRUG TEST KEY CUPS |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-09 |
| Decision Date | 2014-03-06 |
| Summary: | summary |