Cleared Traditional

STA-VWF CALIBRATOR KIT

K962671 · American Bioproducts Co. · Hematology
Sep 1996
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K962671 is an FDA 510(k) clearance for the STA-VWF CALIBRATOR KIT, a Plasma, Coagulation Factor Deficient (Class II — Special Controls, product code GJT), submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on September 13, 1996, 66 days after receiving the submission on July 9, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K962671 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 1996
Decision Date September 13, 1996
Days to Decision 66 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJT — Plasma, Coagulation Factor Deficient
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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