Cleared Traditional

STA SYSTEM CONTROL [N] + [P] KIT

K943518 · American Bioproducts Co. · Hematology
Mar 1995
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K943518 is an FDA 510(k) clearance for the STA SYSTEM 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 March 21, 1995, 243 days after receiving the submission on July 21, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K943518 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1994
Decision Date March 21, 1995
Days to Decision 243 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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