FDA 510(k) Application Details - K200811

Device Classification Name	Counter, Urine Particle   More FDA Info for this Device
510(K) Number	K200811
Device Name	Counter, Urine Particle
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 US Other 510(k) Applications for this Company
Contact	Teresa Carrow Other 510(k) Applications for this Contact
Regulation Number	864.5200   More FDA Info for this Regulation Number
Classification Product Code	LKM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2020
Decision Date	11/06/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review