FDA 510(k) Application Details - K023268

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K023268
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE NATICK, MA 01760 US Other 510(k) Applications for this Company
Contact	RAM NUNNA 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	09/30/2002
Decision Date	11/15/2002
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