FDA 510(k) Application Details - K974651

Device Classification Name	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use   More FDA Info for this Device
510(K) Number	K974651
Device Name	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Applicant	ABBOTT LABORATORIES 200 ABBOTT PARK RD. ABBOTT PARK,, IL 60064-3537 US Other 510(k) Applications for this Company
Contact	PATTY O'BRIEN Other 510(k) Applications for this Contact
Regulation Number	862.2160   More FDA Info for this Regulation Number
Classification Product Code	JJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/1997
Decision Date	02/12/1998
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