The following data is part of a premarket notification filed by Ucp Biosciences, Inc. with the FDA for Ucp Rapid Drug Screening Tricyclic Antidepressant, Propoxyphene Tests.
| Device ID | K061457 |
| 510k Number | K061457 |
| Device Name: | UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS |
| Classification | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| 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 | LFG |
| CFR Regulation Number | 862.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-25 |
| Decision Date | 2006-08-21 |
| Summary: | summary |