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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Factor Deficient
510(k) Number K935851
Device Name BIOMERIEUX HEMOLAB COFAC X
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 Number864.7290
Classification Product Code
GJT  
Date Received12/08/1993
Decision Date 01/17/1995
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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