The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Anaton.
| Device ID | K801046 |
| 510k Number | K801046 |
| Device Name: | ANATON |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | ARMKEL, LLC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-05 |
| Decision Date | 1980-05-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ANATON 73254368 1172750 Dead/Cancelled |
Carter-Wallace, Inc. 1980-03-17 |