The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Immunex Crp.
| Device ID | K812881 |
| 510k Number | K812881 |
| Device Name: | IMMUNEX CRP |
| Classification | System, Test, C-reactive Protein |
| Applicant | ARMKEL, LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| 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 |
|---|---|
![]() IMMUNEX CRP 73342424 1312857 Live/Registered |
Carter-Wallace, Inc. 1981-12-18 |