FDA 510(k) Application Details - K100060

Device Classification Name	Enzymatic, Carbon-Dioxide   More FDA Info for this Device
510(K) Number	K100060
Device Name	Enzymatic, Carbon-Dioxide
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	862.1160   More FDA Info for this Regulation Number
Classification Product Code	KHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/2010
Decision Date	12/15/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review