FDA 510(k) Application Details - K972788

Device Classification Name	Column Chromatography & Color Development, Hydroxyproline   More FDA Info for this Device
510(K) Number	K972788
Device Name	Column Chromatography & Color Development, Hydroxyproline
Applicant	DEVICES AND DIAGNOSTICS CONSULTING GROUP 16809 BRIARDALE RD. ROCKVILLE, MD 20855 US Other 510(k) Applications for this Company
Contact	TOM TSAKARIS 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	07/28/1997
Decision Date	12/22/1998
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