REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT— 510(k) K972005

Name: FDA 510(k) clearance K972005
Creator: U.S. Food and Drug Administration
Published: 1997-08-13

Substantially Equivalent

Reaads Medical Products, Inc.

FDA 510(k) clearance K972005 for REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT, Substantially Equivalent on 1997-08-13. Applicant: Reaads Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Reaads Medical Products, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1997-05-30
Decision date: 1997-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, CO, US

Download summary PDF View on FDA.gov ↗

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