FDA 510(k) Application Details - K963640

Device Classification Name	Acid Phosphatase, Naphthyl Phosphate   More FDA Info for this Device
510(K) Number	K963640
Device Name	Acid Phosphatase, Naphthyl Phosphate
Applicant	OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. MELVILLE, NY 11747-3157 US Other 510(k) Applications for this Company
Contact	LAURA STORMS-TYLER 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	09/12/1996
Decision Date	02/18/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review