FDA 510(k) Application Details - K181017

Device Classification Name	Radioimmunoassay, Testosterones And Dihydrotestosterone   More FDA Info for this Device
510(K) Number	K181017
Device Name	Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant	Monobind Inc. 100 North Pointe Drive Lake Forest, CA 92630 US Other 510(k) Applications for this Company
Contact	Anthony Shatola 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	04/10/2018
Decision Date	07/20/2018
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