Cleared Traditional

STA LIATEST CONTROL [N]+[P] KIT

K964716 · American Bioproducts Co. · Hematology
Jun 1997
Decision
213d
Days
Class 2
Risk

About This 510(k) Submission

K964716 is an FDA 510(k) clearance for the STA LIATEST 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 June 26, 1997, 213 days after receiving the submission on November 25, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K964716 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 1996
Decision Date June 26, 1997
Days to Decision 213 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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