FDA 510(k) Application Details - K023330

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K023330
Device Name	Diazo Colorimetry, Bilirubin
Applicant	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN C1E 2A6 CA Other 510(k) Applications for this Company
Contact	NANCY OLSCAMP 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	10/04/2002
Decision Date	12/11/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review