The following data is part of a premarket notification filed by Ucp Biosciences, Inc. with the FDA for Ucp Pregnancy Cassette Test, Dip/card Strip, Home Pregnancy Cassette Test, Midstream Test And Dip/card Strip.
| Device ID | K131236 |
| 510k Number | K131236 |
| Device Name: | UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| 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 | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-01 |
| Decision Date | 2013-11-07 |
| Summary: | summary |