FDA 510(k) Application Details - K971817

Device Classification Name	Atp And Creatine Kinase (Enzymatic), Creatine   More FDA Info for this Device
510(K) Number	K971817
Device Name	Atp And Creatine Kinase (Enzymatic), Creatine
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	862.1210   More FDA Info for this Regulation Number
Classification Product Code	JLB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/1997
Decision Date	06/11/1997
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