Cleared Traditional

CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER

K900685 · Texas Intl. Laboratories, Inc. · Hematology
Apr 1990
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K900685 is an FDA 510(k) clearance for the CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER, a Instrument, Coagulation (Class II — Special Controls, product code KQG), submitted by Texas Intl. Laboratories, Inc. (Needham, US). The FDA issued a Cleared decision on April 16, 1990, 63 days after receiving the submission on February 12, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number K900685 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1990
Decision Date April 16, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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

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