FDA 510(k) Application Details - K200595

Device Classification Name	Device, Automated Cell-Locating   More FDA Info for this Device
510(K) Number	K200595
Device Name	Device, Automated Cell-Locating
Applicant	CellaVision AB Mobilvagen 12 Lund 22362 SE Other 510(k) Applications for this Company
Contact	Magnus Johnsson Other 510(k) Applications for this Contact
Regulation Number	864.5260   More FDA Info for this Regulation Number
Classification Product Code	JOY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2020
Decision Date	10/16/2020
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