RUBELLA ELISA REAGENTS RUBELLA IGG ANTI— 510(k) K802102

Name: FDA 510(k) clearance K802102
Creator: U.S. Food and Drug Administration
Published: 1980-12-18

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K802102 for RUBELLA ELISA REAGENTS RUBELLA IGG ANTI, Substantially Equivalent on 1980-12-18. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code GOL
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1980-09-03
Decision date: 1980-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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