Cleared Traditional

THROMBIN CLOT TIME TEST PROCEDURE

K923220 · Medical Laboratory Automation Systems, Inc. · Hematology
Sep 1992
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K923220 is an FDA 510(k) clearance for the THROMBIN CLOT TIME TEST PROCEDURE, a Test, Thrombin Time (Class II — Special Controls, product code GJA), submitted by Medical Laboratory Automation Systems, Inc. (Pleasantville, US). The FDA issued a Cleared decision on September 29, 1992, 90 days after receiving the submission on July 1, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7875.

Submission Details

510(k) Number K923220 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1992
Decision Date September 29, 1992
Days to Decision 90 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