FDA 510(k) Application Details - K171315

Device Classification Name	Device, Automated Cell-Locating   More FDA Info for this Device
510(K) Number	K171315
Device Name	Device, Automated Cell-Locating
Applicant	Cella Vision AB Ideon Science Park Lund SE-223 70 SE Other 510(k) Applications for this Company
Contact	Cella Vision AB 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	05/04/2017
Decision Date	08/01/2017
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