FDA 510(k) Application Details - K191350

Device Classification Name	Radioimmunoassay, Testosterones And Dihydrotestosterone   More FDA Info for this Device
510(K) Number	K191350
Device Name	Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant	Immunotech s.r.o. Radiova 1 Prague 10227 CZ Other 510(k) Applications for this Company
Contact	Vit Oburka 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	05/20/2019
Decision Date	12/20/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review