FDA 510(k) Application Details - K063845

Device Classification Name	Enzymatic Method, Bilirubin   More FDA Info for this Device
510(K) Number	K063845
Device Name	Enzymatic Method, Bilirubin
Applicant	BAYER HEALTHCARE, LLC 511 BENEDICT AVE. TARRYTOWN, NY 10591-5097 US Other 510(k) Applications for this Company
Contact	PHILIP LIU Other 510(k) Applications for this Contact
Regulation Number	862.1110   More FDA Info for this Regulation Number
Classification Product Code	JFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2006
Decision Date	12/07/2007
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