FDA 510(k) Application Details - DEN170070

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170070
Device Name	MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /M
Applicant	Cytocell Ltd 3-4 Technopark, Newmarket Road Cambridge cb5 8pb GB Other 510(k) Applications for this Company
Contact	Xavier Baker Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2017
Decision Date	12/21/2018
Decision	DENG -
Classification Advisory Committee	MG -
Review Advisory Committee	MG -
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review