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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, Partial Thromboplastin
510(k) Number K083729
Device Name HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN
Applicant
Aniara Diagnostica, LLC
6560 Gove Court
Mason,  OH  45040
Applicant Contact OLA ANDERSON
Correspondent
Aniara Diagnostica, LLC
6560 Gove Court
Mason,  OH  45040
Correspondent Contact OLA ANDERSON
Regulation Number864.7925
Classification Product Code
GGW  
Subsequent Product Codes
GGN   JIT  
Date Received12/16/2008
Decision Date 05/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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