Cleared Traditional

STA - VWF CONTROL [N]+[P] KIT

K962674 · American Bioproducts Co. · Hematology
Jul 1996
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K962674 is an FDA 510(k) clearance for the STA - VWF CONTROL [N]+[P] KIT, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on July 23, 1996, 14 days after receiving the submission on July 9, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K962674 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 1996
Decision Date July 23, 1996
Days to Decision 14 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGN — Plasma, Coagulation Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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