Cleared Traditional

SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

K000398 · Shield Diagnostics, Ltd. · Hematology
Apr 2000
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K000398 is an FDA 510(k) clearance for the SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on April 17, 2000, 70 days after receiving the submission on February 7, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K000398 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2000
Decision Date April 17, 2000
Days to Decision 70 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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