FDA 510(k) Application Details - K110394

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K110394
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD 189-199 BROWNS RD NOBLE PARK, VICTORIA 3174 AU Other 510(k) Applications for this Company
Contact	MELITA LAMBIRIS 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	02/11/2011
Decision Date	06/09/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review