FDA 510(k) Application Details - K953452

Device Classification Name	Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase   More FDA Info for this Device
510(K) Number	K953452
Device Name	Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Applicant	IHARA MEDICS U.S., INC. 25030 AVENUE TIBBITS, UNIT K VALENCIA, CA 91355 US Other 510(k) Applications for this Company
Contact	LEONARD SPOLTER Other 510(k) Applications for this Contact
Regulation Number	862.1380   More FDA Info for this Regulation Number
Classification Product Code	JMK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/1995
Decision Date	05/02/1996
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