DAE · Class II · 21 CFR 866.5240

FDA Product Code DAE: Complement C9, Antigen, Antiserum, Control

Leading manufacturers include The Binding Site Group , Ltd., The Binding Site, Ltd. and Incstar Corp..

6
Total
6
Cleared
174d
Avg days
1995
Since

FDA 510(k) Cleared Complement C9, Antigen, Antiserum, Control Devices (Product Code DAE)

6 devices
1–6 of 6
Cleared Aug 28, 2015
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
K150412
The Binding Site Group , Ltd.
Immunology · 191d
Cleared Jul 11, 2012
HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
K113349
The Binding Site Group , Ltd.
Immunology · 240d
Cleared Sep 17, 1999
TOTAL HAEMOLYTIC COMPLEMENT RID KIT
K992488
The Binding Site, Ltd.
Immunology · 53d
Cleared Jul 29, 1998
QUIDEL CH50 EQ EIA
K974111
Quidel Corp.
Immunology · 271d
Cleared Dec 18, 1995
WAKO AUTOKIT CH50
K954145
Wako Chemicals USA, Inc.
Immunology · 104d
Cleared Oct 13, 1995
COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
K951639
Incstar Corp.
Immunology · 186d

About Product Code DAE - Regulatory Context