FDA 510(k) Application Details - K171401

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K171401
Device Name	Diazo Colorimetry, Bilirubin
Applicant	ELITechGroup Zone Industrielle Sees 61500 FR Other 510(k) Applications for this Company
Contact	Valerie Gourdon 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	05/12/2017
Decision Date	07/11/2017
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