Cleared Traditional

PACIFIC HEMOSTASIS THROMBOSCREEN 200

K991321 · Pacific Hemostasis · Hematology
Jun 1999
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K991321 is an FDA 510(k) clearance for the PACIFIC HEMOSTASIS THROMBOSCREEN 200, a Instrument, Coagulation (Class II — Special Controls, product code KQG), submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on June 21, 1999, 63 days after receiving the submission on April 19, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number K991321 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1999
Decision Date June 21, 1999
Days to Decision 63 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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