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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Fibrinogen
510(k) Number K042919
Device Name FIBROTEK FIB
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 Number864.7340
Classification Product Code
GIS  
Subsequent Product Code
KQJ  
Date Received10/22/2004
Decision Date 11/29/2004
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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