FDA 510(k) Application Details - K990843

Device Classification Name	Column Chromatography & Color Development, Hydroxyproline   More FDA Info for this Device
510(K) Number	K990843
Device Name	Column Chromatography & Color Development, Hydroxyproline
Applicant	OSTEOMETER BIOTECH A/S HERLEV HOVEDGADE 207 HERLEV DK-2730 DK Other 510(k) Applications for this Company
Contact	PER QVIST 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	03/15/1999
Decision Date	07/09/1999
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