FDA 510(k) Application Details - K973177

Device Classification Name	Analyzer, Chemistry, Micro, For Clinical Use   More FDA Info for this Device
510(K) Number	K973177
Device Name	Analyzer, Chemistry, Micro, For Clinical Use
Applicant	DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US Other 510(k) Applications for this Company
Contact	LYNNE STIRLING Other 510(k) Applications for this Contact
Regulation Number	862.2170   More FDA Info for this Regulation Number
Classification Product Code	JJF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/1997
Decision Date	10/09/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review