FDA 510(k) Application Details - K023840

Device Classification Name	Acid Phosphatase, Naphthyl Phosphate   More FDA Info for this Device
510(K) Number	K023840
Device Name	Acid Phosphatase, Naphthyl Phosphate
Applicant	BAYER DIAGNOSTICS CORP. 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	862.1020   More FDA Info for this Regulation Number
Classification Product Code	CKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2002
Decision Date	01/07/2003
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