Cleared Traditional

THROMBOSTRATE CONTROL PLASMAS

K000679 · Pacific Hemostasis · Hematology
Mar 2000
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K000679 is an FDA 510(k) clearance for the THROMBOSTRATE CONTROL PLASMAS, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on March 24, 2000, 24 days after receiving the submission on February 29, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K000679 FDA.gov
FDA Decision Cleared SESE
Date Received February 29, 2000
Decision Date March 24, 2000
Days to Decision 24 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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