IMMUNOGLOBULIN M REAGENT SYSTEM— 510(k) K800167

Name: FDA 510(k) clearance K800167
Creator: U.S. Food and Drug Administration
Published: 1980-02-05

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K800167 for IMMUNOGLOBULIN M REAGENT SYSTEM, Substantially Equivalent on 1980-02-05. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1980-01-25
Decision date: 1980-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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