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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 K925493
Device Name BIOMERIEUX HEMOLAB THROMBICALCI-TEST
Applicant
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042
Applicant Contact CHERYL WINTERS-HEARD
Correspondent
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042
Correspondent Contact CHERYL WINTERS-HEARD
Regulation Number864.7875
Classification Product Code
GJA  
Date Received11/02/1992
Decision Date 04/21/1994
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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