FDA 510(k) Application Details - K032936

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K032936
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US Other 510(k) Applications for this Company
Contact	ADAOBI OGUCHI Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/2003
Decision Date	03/12/2004
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