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

FDA 510(k) Number Applicant Device Name Decision Date
K951639 INCSTAR CORP. COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) 10/13/1995
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
K954145 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT CH50 12/18/1995


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