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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 K073537
Device Name NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
Applicant
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
2 EDGEWATER DR.
NORWOOD,  MA  02062
Applicant Contact NOOR MALKI
Correspondent
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
2 EDGEWATER DR.
NORWOOD,  MA  02062
Correspondent Contact NOOR MALKI
Regulation Number862.1113
Classification Product Code
MQM  
Date Received12/17/2007
Decision Date 06/27/2008
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
Recalls CDRH Recalls
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