FDA 510(k) Application Details - K022180

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K022180
Device Name	Diazo Colorimetry, Bilirubin
Applicant	ABBOTT LABORATORIES 1920 HURD DR. IRVING, TX 75038 US Other 510(k) Applications for this Company
Contact	MICHELE SMITH-WAHEED 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	07/03/2002
Decision Date	09/06/2002
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