Cleared Traditional

SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY

K962825 · Shield Diagnostics, Ltd. · Hematology
Nov 1996
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K962825 is an FDA 510(k) clearance for the SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY, 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 November 15, 1996, 119 days after receiving the submission on July 19, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K962825 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1996
Decision Date November 15, 1996
Days to Decision 119 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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