FDA 510(k) Application Details - K221801

Device Classification Name	More FDA Info for this Device
510(K) Number	K221801
Device Name	ADVIA Centaur« Anti-Mⁿllerian Hormone (AMH)
Applicant	Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591-5097 US Other 510(k) Applications for this Company
Contact	Mey Vasquez Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2022
Decision Date	06/02/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review