The following data is part of a premarket notification filed by Ucp Biosciences, Inc. with the FDA for Ucp Home Drug Screening Test Cups.
| Device ID | K122419 |
| 510k Number | K122419 |
| Device Name: | UCP HOME DRUG SCREENING TEST 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 | 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 | 2012-08-09 |
| Decision Date | 2012-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850721007123 | K122419 | 000 |
| 20817038020566 | K122419 | 000 |
| 20817038020573 | K122419 | 000 |
| 20817038020627 | K122419 | 000 |
| 20817038020658 | K122419 | 000 |
| 20817038020665 | K122419 | 000 |
| 20817038021587 | K122419 | 000 |
| 20817038021600 | K122419 | 000 |
| 20817038021617 | K122419 | 000 |
| 20817038021624 | K122419 | 000 |
| 10850721007034 | K122419 | 000 |
| 20850721007055 | K122419 | 000 |
| 20850721007109 | K122419 | 000 |
| 20850721007116 | K122419 | 000 |
| 20817038022195 | K122419 | 000 |