FDA 510(k) Application Details - K061139

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K061139
Device Name	Calibrator, Secondary
Applicant	BAYER HEALTHCARE, LLC 511 BENEDICT AVE. TARRYTOWN, NY 10591-5097 US Other 510(k) Applications for this Company
Contact	ANDRES HOLLE Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2006
Decision Date	07/06/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review