FDA 510(k) Application Details - K082210

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K082210
Device Name	Diazo Colorimetry, Bilirubin
Applicant	GENZYME DIAGNOSTICS P.E.I. INC. 70 WATTS AVENUE CHARLOTTETOWN, PRIN ED ISLAND C1E 2B9 CA Other 510(k) Applications for this Company
Contact	PENNY J WHITE Other 510(k) Applications for this Contact
Regulation Number	862.1110   More FDA Info for this Regulation Number
Classification Product Code	CIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2008
Decision Date	12/16/2008
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