510(k) K113349
- Device
- HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
- Applicant
- THE BINDING SITE GROUP LTD
- 510(k) number
- K113349
- Product code
- DAE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-07-11
- Date received
- 2011-11-14
- Regulation
- 866.5240
- Classification name
- Complement C9, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARIANNE SENDER
- Address
- 8 Calthorpe Rd. Birmingham GB B15 1QT B15 1QT
FDA Registration Numbers#
- 3003522182
- 9614373
- 3003419906
- 3012471076
- 2182595
- 1528450
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DAE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator | The Binding Site Group , Ltd. | 2015-08-28 |
| K992488 | TOTAL HAEMOLYTIC COMPLEMENT RID KIT | The Binding Site, Ltd. | 1999-09-17 |
| K974111 | QUIDEL CH50 EQ EIA | Quidel Corp. | 1998-07-29 |
| K954145 | WAKO AUTOKIT CH50 | Wako Chemicals USA, Inc. | 1995-12-18 |
| K951639 | COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) | Incstar Corp. | 1995-10-13 |
Legacy Summary#
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FDA Review#
Decision Summary