FDA 510(k) Application Details - K193649

Device Classification Name	Enzymatic Method, Creatinine   More FDA Info for this Device
510(K) Number	K193649
Device Name	Enzymatic Method, Creatinine
Applicant	Horiba ABX SAS Parc Euromedecine Montpellier Cedex 4 341184 FR Other 510(k) Applications for this Company
Contact	Caroline Ferrer Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	JFY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2019
Decision Date	05/10/2021
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