FDA 510(k) Application Details - K133175

Device Classification Name	Bilirubin (Total And Unbound) In The Neonate Test System   More FDA Info for this Device
510(K) Number	K133175
Device Name	Bilirubin (Total And Unbound) In The Neonate Test System
Applicant	DRAEGER MEDICAL SYSTEMS, INC. 3135 QUARRY RD. TELFORD, PA 18969 US Other 510(k) Applications for this Company
Contact	BRYAN OVERTON 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	10/17/2013
Decision Date	11/13/2014
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