The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Ucg-beta Stat.
Device ID | K802421 |
510k Number | K802421 |
Device Name: | UCG-BETA STAT |
Classification | Agglutination Method, Human Chorionic Gonadotropin |
Applicant | ARMKEL, LLC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JHJ |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-06 |
Decision Date | 1980-10-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
UCG-BETA STAT 73290053 1237865 Dead/Cancelled |
Carter-Wallace, Inc. 1980-12-16 |