FDA 510(k) Application Details - K963251

Device Classification Name	Column Chromatography & Color Development, Hydroxyproline   More FDA Info for this Device
510(K) Number	K963251
Device Name	Column Chromatography & Color Development, Hydroxyproline
Applicant	CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. IRVINE, CA 92714 US Other 510(k) Applications for this Company
Contact	William J Pignato Other 510(k) Applications for this Contact
Regulation Number	862.1400   More FDA Info for this Regulation Number
Classification Product Code	JMM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/1996
Decision Date	10/15/1996
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