FDA 510(k) Application Details - K190121

Device Classification Name	Radioimmunoassay, Testosterones And Dihydrotestosterone   More FDA Info for this Device
510(K) Number	K190121
Device Name	Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant	Immunodiagnostic Systems Ltd. 10 Didcot Way Boldon Business Park Boldon NE35 9PD GB Other 510(k) Applications for this Company
Contact	Mick Henderson Other 510(k) Applications for this Contact
Regulation Number	862.1680   More FDA Info for this Regulation Number
Classification Product Code	CDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2019
Decision Date	06/17/2019
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