FDA 510(k) Application Details - K223078

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K223078
Device Name	Diazo Colorimetry, Bilirubin
Applicant	Siemens Healthcare Diagnostics Inc. 500 GBC Drive, M/S 514, PO Box 6101 Newark, DE 19714 US Other 510(k) Applications for this Company
Contact	Anthony Calabro 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	09/30/2022
Decision Date	06/12/2023
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