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 |