FDA 510(k) Application Details - K011052

Device Classification Name	Column Chromatography & Color Development, Hydroxyproline   More FDA Info for this Device
510(K) Number	K011052
Device Name	Column Chromatography & Color Development, Hydroxyproline
Applicant	OSTEX INTL., INC. 2203 AIRPORT WAY SOUTH, SUITE 400 SEATTLE, WA 98134 US Other 510(k) Applications for this Company
Contact	NANCY JS MALLINAK 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	04/06/2001
Decision Date	07/30/2001
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