FDA 510(k) Application Details - K202826

Device Classification Name	Radioimmunoassay, Cortisol   More FDA Info for this Device
510(K) Number	K202826
Device Name	Radioimmunoassay, Cortisol
Applicant	Siemens Healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis Caernarfon LL55 4EL GB Other 510(k) Applications for this Company
Contact	Malgorzata Robak Other 510(k) Applications for this Contact
Regulation Number	862.1205   More FDA Info for this Regulation Number
Classification Product Code	CGR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2020
Decision Date	01/15/2021
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