The following data is part of a premarket notification filed by Wampole Laboratories with the FDA for Ucg-lyphotest.
| Device ID | K791309 |
| 510k Number | K791309 |
| Device Name: | UCG-LYPHOTEST |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | WAMPOLE LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-16 |
| Decision Date | 1979-07-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() UCG-LYPHOTEST 73190851 1129090 Dead/Cancelled |
CARTER-WALLACE, INC. 1978-10-26 |