CYFRA 21-1 EIA MODEL 211-10— 510(k) K100831

Name: FDA 510(k) clearance K100831
Creator: U.S. Food and Drug Administration
Published: 2011-05-26

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K100831 for CYFRA 21-1 EIA MODEL 211-10, Substantially Equivalent on 2011-05-26. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code OVK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2010-03-24
Decision date: 2011-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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