FDA 510(k) Application Details - K983304

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K983304
Device Name	Diazo Colorimetry, Bilirubin
Applicant	SYNERMED INTL., INC. 1688 50TH AVE. LACHINE, QUEBEC H8T 2V5 CA Other 510(k) Applications for this Company
Contact	MARCIA J ARENTZ 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	09/21/1998
Decision Date	11/04/1998
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