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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Hemoglobin
510(k) Number K070334
Device Name R&D SICKLE QC CONTROL
Applicant
R&D Systems, Inc.
614 Mckinley Pl. NE
Minneapolis,  MN  55413
Applicant Contact RALPH E HOGANCAMP
Correspondent
R&D Systems, Inc.
614 Mckinley Pl. NE
Minneapolis,  MN  55413
Correspondent Contact RALPH E HOGANCAMP
Regulation Number864.8625
Classification Product Code
GGM  
Date Received02/05/2007
Decision Date 03/29/2007
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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