Cleared Traditional

AT-III CONTROL PLASMA KIT

K955040 · American Bioproducts Co. · Hematology
Jan 1996
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K955040 is an FDA 510(k) clearance for the AT-III CONTROL PLASMA KIT, a Control, Plasma, Abnormal (Class II — Special Controls, product code GGC), submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on January 31, 1996, 89 days after receiving the submission on November 3, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K955040 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1995
Decision Date January 31, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGC — Control, Plasma, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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