Cleared Traditional

VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL

K022046 · Vital Scientific N.V. · Hematology
Jul 2002
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K022046 is an FDA 510(k) clearance for the VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Vital Scientific N.V. (Newton, US). The FDA issued a Cleared decision on July 23, 2002, 29 days after receiving the submission on June 24, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K022046 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2002
Decision Date July 23, 2002
Days to Decision 29 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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