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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 K090105
Device Name LUPOTEK KCT
Applicant
R2 DIAGNOSTICS, INC.
1801 COMMERCE DR.
SOUTH BEND,  IN  46628
Applicant Contact MARC D GOLDFORD
Correspondent
R2 DIAGNOSTICS, INC.
1801 COMMERCE DR.
SOUTH BEND,  IN  46628
Correspondent Contact MARC D GOLDFORD
Regulation Number864.7925
Classification Product Code
GGW  
Date Received01/15/2009
Decision Date 12/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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