ENA TEST KIT SM & RNP AUTO ANTIBODY— 510(k) K831036

Name: FDA 510(k) clearance K831036
Creator: U.S. Food and Drug Administration
Published: 1983-04-27

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K831036 for ENA TEST KIT SM & RNP AUTO ANTIBODY, Substantially Equivalent on 1983-04-27. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1983-03-31
Decision date: 1983-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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