Cleared Traditional

THROMBIN CLOTTING TIME REAGENT

K920147 · Helena Laboratories · Hematology
May 1992
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K920147 is an FDA 510(k) clearance for the THROMBIN CLOTTING TIME REAGENT, a Test, Thrombin Time (Class II — Special Controls, product code GJA), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on May 1, 1992, 109 days after receiving the submission on January 13, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7875.

Submission Details

510(k) Number K920147 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1992
Decision Date May 01, 1992
Days to Decision 109 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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

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