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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K062306
Device Name PLASMACON N, PLASMACON L-1, PLASMACON L-2
Applicant
R2 Diagnostics, Inc.
1801 Commerce Dr.
South Bend,  IN  46628
Applicant Contact MARC GOLDFORD
Correspondent
R2 Diagnostics, Inc.
1801 Commerce Dr.
South Bend,  IN  46628
Correspondent Contact MARC GOLDFORD
Regulation Number864.5425
Classification Product Code
GGC  
Subsequent Product Code
GIZ  
Date Received08/08/2006
Decision Date 03/16/2007
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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