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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bilirubin (Total And Unbound) In The Neonate Test System
510(k) Number K110277
Device Name RAPIDPOINT 405 NEONATAL BILIRUBIN
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
2 EDGEWATER DRIVE
NORWOOD,  MA  02062
Applicant Contact Steven Goldberg
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
2 EDGEWATER DRIVE
NORWOOD,  MA  02062
Correspondent Contact Steven Goldberg
Regulation Number862.1113
Classification Product Code
MQM  
Date Received01/31/2011
Decision Date 08/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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