The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Rheumatoid Factor Reference Prepara..
| Device ID | K821941 |
| 510k Number | K821941 |
| Device Name: | RHEUMATOID FACTOR REFERENCE PREPARA. |
| 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 | 1982-06-29 |
| Decision Date | 1982-08-27 |