FDA 510(k) Applications for Medical Device Product Code "DAE"
|
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 |