FDA 510(k) Application Details - K041133

Device Classification Name	Radioassay, Vitamin B12   More FDA Info for this Device
510(K) Number	K041133
Device Name	Radioassay, Vitamin B12
Applicant	BAYER HEALTHCARE, LLC 511 BENEDICT AVE. TARRYTOWN, NY 10591 US Other 510(k) Applications for this Company
Contact	ANDRES HOLLE Other 510(k) Applications for this Contact
Regulation Number	862.1810   More FDA Info for this Regulation Number
Classification Product Code	CDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2004
Decision Date	07/02/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review