FDA 510(k) Applications for Medical Device Product Code "DAE"
(Complement C9, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K974111 QUIDEL CORP. QUIDEL CH50 EQ EIA 07/29/1998
K113349 THE BINDING SITE GROUP LTD HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO 07/11/2012
K150412 The Binding Site Group Ltd Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator 08/28/2015
K992488 THE BINDING SITE, LTD. TOTAL HAEMOLYTIC COMPLEMENT RID KIT 09/17/1999


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