Cleared Traditional

COAGULATION CONTROL, LEVEL II

K902362 · Sigma Chemical Co. · Hematology
Jul 1990
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K902362 is an FDA 510(k) clearance for the COAGULATION CONTROL, LEVEL II, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on July 26, 1990, 58 days after receiving the submission on May 29, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K902362 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1990
Decision Date July 26, 1990
Days to Decision 58 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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

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