FDA 510(k) Application Details - K182012

Device Classification Name	Radioimmunoassay, Calcitonin   More FDA Info for this Device
510(K) Number	K182012
Device Name	Radioimmunoassay, Calcitonin
Applicant	Axis-Shield Diagnostics Limited Luna Place, The Technology Park Dundee DD2 1XA GB Other 510(k) Applications for this Company
Contact	Claire Dora Other 510(k) Applications for this Contact
Regulation Number	862.1140   More FDA Info for this Regulation Number
Classification Product Code	JKR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2018
Decision Date	12/21/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review