RHEUMATEX— 510(k) K812882

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K812882 for RHEUMATEX, Substantially Equivalent on 1981-10-26. 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: 1981-10-14
Decision date: 1981-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.