Cleared Traditional

STA-COAG CONTROL [P] PLUS KIT

K952338 · American Bioproducts Co. · Hematology
Sep 1995
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K952338 is an FDA 510(k) clearance for the STA-COAG CONTROL [P] PLUS 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 September 21, 1995, 125 days after receiving the submission on May 19, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K952338 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1995
Decision Date September 21, 1995
Days to Decision 125 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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