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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 K033471
Device Name PHOSPHOLIN ES AND CALCIUM CHLORIDE
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 Number864.7925
Classification Product Code
GGW  
Date Received11/03/2003
Decision Date 02/04/2004
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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