FDA 510(k) Application Details - K070064

Device Classification Name	Catalytic Methods, Amylase   More FDA Info for this Device
510(K) Number	K070064
Device Name	Catalytic Methods, Amylase
Applicant	Thermo Fisher Scientific 189-199 BROWNS RD. NOBLE PARK, VICTORIA 3174 AU Other 510(k) Applications for this Company
Contact	MELITA LAMBIRIS Other 510(k) Applications for this Contact
Regulation Number	862.1070   More FDA Info for this Regulation Number
Classification Product Code	JFJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2007
Decision Date	05/22/2007
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