RHEUMATOID FACTOR REFERENCE PREPARA.— 510(k) K821941

Name: FDA 510(k) clearance K821941
Creator: U.S. Food and Drug Administration
Published: 1982-08-27

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K821941 for RHEUMATOID FACTOR REFERENCE PREPARA., Substantially Equivalent on 1982-08-27. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1982-06-29
Decision date: 1982-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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