VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN— 510(k) K110432

Name: FDA 510(k) clearance K110432
Creator: U.S. Food and Drug Administration
Published: 2011-10-20

Substantially Equivalent

Affinity Biologicals, Inc.

FDA 510(k) clearance K110432 for VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN, Substantially Equivalent on 2011-10-20. Applicant: Affinity Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: Affinity Biologicals, Inc.
Product code: Code GGN
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2011-02-15
Decision date: 2011-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ancaster, Ontario, CA

Download summary PDF View on FDA.gov ↗

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