FDA 510(k) Application Details - K220262

Device Classification Name	More FDA Info for this Device
510(K) Number	K220262
Device Name	Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
Applicant	Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, P.O. Box 6101 Mail Stop 514 Newark, DE 19714 US Other 510(k) Applications for this Company
Contact	Amy Tyler Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PRI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2022
Decision Date	08/26/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review