FDA 510(k) Application Details - K962113

Device Classification Name	Colorimeter, Photometer, Spectrophotometer For Clinical Use   More FDA Info for this Device
510(K) Number	K962113
Device Name	Colorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant	COLUMBIA BIOSCIENCE, INC. 182 THOMAS JOHSON DR. SUITE 205 FREDERICK, MD 21702 US Other 510(k) Applications for this Company
Contact	NORMAN JENKINS 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	05/31/1996
Decision Date	11/05/1996
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