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FDA 510(k) Application Details - K170882
Device Classification Name
Bilirubin (Total And Unbound) In The Neonate Test System
More FDA Info for this Device
510(K) Number
K170882
Device Name
Bilirubin (Total And Unbound) In The Neonate Test System
Applicant
Radiometer Medical ApS
Aakandevej 21
Broenshoej DK-2700 DK
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Contact
Soren Boegestrand
Other 510(k) Applications for this Contact
Regulation Number
862.1113
More FDA Info for this Regulation Number
Classification Product Code
MQM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/24/2017
Decision Date
04/28/2017
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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