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 |