FDA 510(k) Application Details - K981609

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K981609
Device Name	Diazo Colorimetry, Bilirubin
Applicant	DIAGNOSTIC CHEMICALS LTD. 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK CHARLOTTETOWN, P.E.I. C1E1B0 CA Other 510(k) Applications for this Company
Contact	KAREN CALLBECK 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	05/05/1998
Decision Date	06/03/1998
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