FDA 510(k) Application Details - K915704

Device Classification Name	Nitrosalicylate Reduction, Amylase   More FDA Info for this Device
510(K) Number	K915704
Device Name	Nitrosalicylate Reduction, Amylase
Applicant	TECH INTL. CO. 911 VIA RODEO PLACENTIA, CA 92670 US Other 510(k) Applications for this Company
Contact	CHEN Other 510(k) Applications for this Contact
Regulation Number	862.1070   More FDA Info for this Regulation Number
Classification Product Code	CJD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/1991
Decision Date	06/28/1996
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