RHEUMATOID FACTORS REFERENCE SERUM— 510(k) K810404

Name: FDA 510(k) clearance K810404
Creator: U.S. Food and Drug Administration
Published: 1981-03-11

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K810404 for RHEUMATOID FACTORS REFERENCE SERUM, Substantially Equivalent on 1981-03-11. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1981-02-18
Decision date: 1981-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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