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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K925492
Device Name BIOMERIEUX HEMOLAB THROMBOMAT
Applicant
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042 -2395
Applicant Contact CHERYL WINTERS-HEARD
Correspondent
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042 -2395
Correspondent Contact CHERYL WINTERS-HEARD
Regulation Number864.7750
Classification Product Code
GJS  
Date Received11/02/1992
Decision Date 02/03/1993
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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