FDA 510(k) Application Details - K020282

Device Classification Name	Catalytic Methods, Amylase   More FDA Info for this Device
510(K) Number	K020282
Device Name	Catalytic Methods, Amylase
Applicant	JAS Diagnostics, Inc. 7220 NW 58TH ST. MIAMI, FL 33166 US Other 510(k) Applications for this Company
Contact	DAVID JOHNSON 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	01/28/2002
Decision Date	02/28/2002
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