SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200— 510(k) K000398

Name: FDA 510(k) clearance K000398
Creator: U.S. Food and Drug Administration
Published: 2000-04-17

Substantially Equivalent

Shield Diagnostics, Ltd.

FDA 510(k) clearance K000398 for SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200, Substantially Equivalent on 2000-04-17. Applicant: Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Shield Diagnostics, Ltd.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2000-02-07
Decision date: 2000-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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