Cleared Traditional

BIOMERIEUX HEMOLAB THROMBICALCI-TEST

K925493 · Biomerieux Vitek, Inc. · Hematology
Apr 1994
Decision
535d
Days
Class 2
Risk

About This 510(k) Submission

K925493 is an FDA 510(k) clearance for the BIOMERIEUX HEMOLAB THROMBICALCI-TEST, a Test, Thrombin Time (Class II — Special Controls, product code GJA), submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on April 21, 1994, 535 days after receiving the submission on November 2, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7875.

Submission Details

510(k) Number K925493 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1992
Decision Date April 21, 1994
Days to Decision 535 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJA — Test, Thrombin Time
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7875

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