FDA 510(k) Application Details - K212223

Device Classification Name	Enzymatic Method, Creatinine   More FDA Info for this Device
510(K) Number	K212223
Device Name	Enzymatic Method, Creatinine
Applicant	Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 US Other 510(k) Applications for this Company
Contact	Ian Thompson 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	07/16/2021
Decision Date	11/24/2021
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