Cleared Traditional

COAGULATION CONTROL LEVEL 1 (NORMAL)

K984129 · Pacific Hemostasis · Hematology
Dec 1998
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K984129 is an FDA 510(k) clearance for the COAGULATION CONTROL LEVEL 1 (NORMAL), a Plasma, Control, Normal (Class II — Special Controls, product code GIZ), submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on December 1, 1998, 13 days after receiving the submission on November 18, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K984129 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1998
Decision Date December 01, 1998
Days to Decision 13 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIZ — Plasma, Control, Normal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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