Cleared Traditional

VON WILLEBRAND FACTOR ASSAY

K802356 · Bio/Data Corp. · Hematology
Dec 1980
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K802356 is an FDA 510(k) clearance for the VON WILLEBRAND FACTOR ASSAY, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Bio/Data Corp. (Walker, US). The FDA issued a Cleared decision on December 1, 1980, 66 days after receiving the submission on September 26, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K802356 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1980
Decision Date December 01, 1980
Days to Decision 66 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

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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