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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abnormal Hemoglobin Quantitation
510(k) Number K080911
Device Name VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
Applicant
Bio-Rad Laboratories Inc., Clinical Systems Divisi
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact J.B BARTILSON
Correspondent
Bio-Rad Laboratories Inc., Clinical Systems Divisi
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact J.B BARTILSON
Regulation Number864.7415
Classification Product Code
GKA  
Date Received04/02/2008
Decision Date 05/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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