FDA 510(k) Application Details - K010052

Device Classification Name	Bilirubin (Total And Unbound) In The Neonate Test System   More FDA Info for this Device
510(K) Number	K010052
Device Name	Bilirubin (Total And Unbound) In The Neonate Test System
Applicant	RESPIRONICS, INC. 125 CHASTAIN MEADOW COURT KENNESAW, GA 30144-3724 US Other 510(k) Applications for this Company
Contact	DAVID J VANELLA 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	01/08/2001
Decision Date	03/19/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review