FDA 510(k) Application Details - K961274

Device Classification Name	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use   More FDA Info for this Device
510(K) Number	K961274
Device Name	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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	862.2160   More FDA Info for this Regulation Number
Classification Product Code	JJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/1996
Decision Date	07/05/1996
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