The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Rheumatex.
Device ID | K812882 |
510k Number | K812882 |
Device Name: | RHEUMATEX |
Classification | System, Test, Rheumatoid Factor |
Applicant | ARMKEL, LLC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-14 |
Decision Date | 1981-10-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RHEUMATEX 73342358 1255680 Live/Registered |
Carter-Wallace, Inc. 1981-12-18 |
RHEUMATEX 72380116 0945830 Dead/Expired |
NEDERLANDS AMERIKAANSE BREI MAATSCHAPPIJ N.V. 1971-01-04 |