FDA 510(k) Application Details - K002156

Device Classification Name	Alkaline Picrate, Colorimetry, Creatinine   More FDA Info for this Device
510(K) Number	K002156
Device Name	Alkaline Picrate, Colorimetry, Creatinine
Applicant	OSBORN GROUP, INC. 14901 WEST 117TH ST. OLATHE, KS 66062 US Other 510(k) Applications for this Company
Contact	GILBERT P BOURK III Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	CGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2000
Decision Date	12/19/2000
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