Cleared Traditional

COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0

K971428 · Pacific Hemostasis · Hematology
Jun 1997
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K971428 is an FDA 510(k) clearance for the COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on June 17, 1997, 61 days after receiving the submission on April 17, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K971428 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1997
Decision Date June 17, 1997
Days to Decision 61 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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