FDA 510(k) Application Details - K973938

Device Classification Name	Colorimeter, Photometer, Spectrophotometer For Clinical Use   More FDA Info for this Device
510(K) Number	K973938
Device Name	Colorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant	SFRI, INC. 2082 MICHELSON DR., #100 IRVINE, CA 92612-1212 US Other 510(k) Applications for this Company
Contact	GERALD ODSTRCHEL Other 510(k) Applications for this Contact
Regulation Number	862.2300   More FDA Info for this Regulation Number
Classification Product Code	JJQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/1997
Decision Date	02/04/1998
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