The following data is part of a premarket notification filed by Ucp Biosciences, Inc with the FDA for Ucp Drug Test Mini Cups.
| Device ID | K151213 |
| 510k Number | K151213 |
| Device Name: | UCP Drug Test Mini 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-06 |
| Decision Date | 2015-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817038021938 | K151213 | 000 |
| 20817038022102 | K151213 | 000 |
| 20817038022089 | K151213 | 000 |
| 20817038020733 | K151213 | 000 |
| 20817038020740 | K151213 | 000 |
| 20817038020757 | K151213 | 000 |
| 20817038020764 | K151213 | 000 |
| 20817038021082 | K151213 | 000 |
| 20817038021747 | K151213 | 000 |
| 20817038021778 | K151213 | 000 |
| 20817038022201 | K151213 | 000 |