Cleared Traditional

VON WILLEBRAND REAGENT

K972116 · Behring Diagnostics, Inc. · Hematology
Jul 1997
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K972116 is an FDA 510(k) clearance for the VON WILLEBRAND REAGENT, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Behring Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on July 25, 1997, 50 days after receiving the submission on June 5, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K972116 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1997
Decision Date July 25, 1997
Days to Decision 50 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

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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