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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Thrombin Time
510(k) Number K923220
Device Name THROMBIN CLOT TIME TEST PROCEDURE
Applicant
Medical Laboratory Automation Systems, Inc.
270 Marble Ave.
Pleasantville,  NY  10570
Applicant Contact JOANN HANCHROW
Correspondent
Medical Laboratory Automation Systems, Inc.
270 Marble Ave.
Pleasantville,  NY  10570
Correspondent Contact JOANN HANCHROW
Regulation Number864.7875
Classification Product Code
GJA  
Date Received07/01/1992
Decision Date 09/29/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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