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FDA 510(k) Application Details - K042522
Device Classification Name
Bilirubin (Total And Unbound) In The Neonate Test System
More FDA Info for this Device
510(K) Number
K042522
Device Name
Bilirubin (Total And Unbound) In The Neonate Test System
Applicant
DRAEGER MEDICAL INFANT CARE, INC.
330 JACKSONVILLE RD.
HATBORO, PA 19040 US
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Contact
THOMAS M MCINTOSH
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
09/16/2004
Decision Date
07/06/2005
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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