AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY— 510(k) K800820

Name: FDA 510(k) clearance K800820
Creator: U.S. Food and Drug Administration
Published: 1980-04-24

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K800820 for AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY, Substantially Equivalent on 1980-04-24. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code DBE
Device class: Class 2
Regulation: 21 CFR 866.5120
Advisory panel: Immunology
Date received: 1980-04-11
Decision date: 1980-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.