Cleared Traditional

PACIFIC HEMOSTASIS THROMBOSCREEN 400C

K992130 · Pacific Hemostasis · Hematology
Sep 1999
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K992130 is an FDA 510(k) clearance for the PACIFIC HEMOSTASIS THROMBOSCREEN 400C, a Instrument, Coagulation (Class II — Special Controls, product code KQG), submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on September 3, 1999, 72 days after receiving the submission on June 23, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number K992130 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1999
Decision Date September 03, 1999
Days to Decision 72 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KQG — Instrument, Coagulation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5400

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