FDA 510(k) Application Details - K192271

Device Classification Name	More FDA Info for this Device
510(K) Number	K192271
Device Name	Access PCT, Access PCT Calibrators
Applicant	Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	Jennifer Bennett Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2019
Decision Date	11/26/2019
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