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 |