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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K082631
Device Name THROMBO TEK PSE, MODEL 90-480
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 Number864.7290
Classification Product Code
GGP  
Date Received09/10/2008
Decision Date 12/17/2008
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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