FDA 510(k) Application Details - K971103

Device Classification Name	Fluorometer, For Clinical Use   More FDA Info for this Device
510(K) Number	K971103
Device Name	Fluorometer, For Clinical Use
Applicant	TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D FOSTER CITY, CA 94404 US Other 510(k) Applications for this Company
Contact	LORI ROBINSON Other 510(k) Applications for this Contact
Regulation Number	862.2560   More FDA Info for this Regulation Number
Classification Product Code	KHO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/1997
Decision Date	06/27/1997
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