FDA 510(k) Application Details - K201908

Device Classification Name	Radioimmunoassay, Testosterones And Dihydrotestosterone   More FDA Info for this Device
510(K) Number	K201908
Device Name	Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant	DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 US Other 510(k) Applications for this Company
Contact	John Walter 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	07/09/2020
Decision Date	10/15/2020
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
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