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FDA 510(k) Application Details - K040174
Device Classification Name
Bilirubin (Total And Unbound) In The Neonate Test System
More FDA Info for this Device
510(K) Number
K040174
Device Name
Bilirubin (Total And Unbound) In The Neonate Test System
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE ROAD
INDIANAPOLIS, IN 46256 US
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Contact
JENNIFER TRIBBETT
Other 510(k) Applications for this Contact
Regulation Number
862.1113
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Classification Product Code
MQM
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More FDA Info for this Product Code
Date Received
01/26/2004
Decision Date
05/14/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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