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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 K050817
Device Name T-TEK
Applicant
R2 Diagnostics, Inc.
412 S. Lafayette Blvd.
South Bend,  IN  46601
Applicant Contact PEGGY S CARTER
Correspondent
R2 Diagnostics, Inc.
412 S. Lafayette Blvd.
South Bend,  IN  46601
Correspondent Contact PEGGY S CARTER
Regulation Number864.7875
Classification Product Code
GJA  
Date Received03/31/2005
Decision Date 12/12/2005
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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