AUTOANTIBODY REAGENTS, AFT SYSTEM II— 510(k) K790280

Name: FDA 510(k) clearance K790280
Creator: U.S. Food and Drug Administration
Published: 1979-04-23

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K790280 for AUTOANTIBODY REAGENTS, AFT SYSTEM II, Substantially Equivalent on 1979-04-23. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1979-02-13
Decision date: 1979-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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