510(k) K122304
- Device
- HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
- Applicant
- THE BINDING SITE GROUP, LTD.
- 510(k) number
- K122304
- Product code
- DBA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-04-15
- Date received
- 2012-08-01
- Regulation
- 866.5250
- Classification name
- Complement C1 Inhibitor (inactivator), 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
- JILL CONSTANTINE
- Address
- 8 Calthorpe Rd. Birmingham GB B15 1QT B15 1QT
FDA Registration Numbers#
- 3019906
- 9610806
- 1528450
- 3012471076
- 9614373
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DBA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K141100 | OPTILITE C1 INACTIVATOR KIT | The Binding Site Group , Ltd. | 2014-07-18 |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | Dade Behring, Inc. | 2007-12-21 |
| K011780 | K-ASSAY C1-INA | Kamiya Biomedical Co. | 2001-07-25 |
| K003747 | C1-INHIBITOR MICROTITER ASSAY DEVICE | Baxter Healthcare Corp | 2001-03-19 |
| K965024 | N-ASSAY TIA C1-INACTIVATOR TEST KIT | Crestat Diagnostics, Inc. | 1997-07-14 |
| K960257 | N ANTISERUM TO C1 INHIBITOR | Behring Diagnostics, Inc. | 1996-08-01 |
| K951967 | HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | 1995-05-30 |
| K915431 | COMPLEMENT C1 INACTIVATOR KIT | The Binding Site, Ltd. | 1992-01-17 |
| K872426 | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY | Cytotech, Inc. | 1987-07-23 |
| K821898 | ORTHO CLASSICAL PATHWAY COMPL. TEST | Ortho Diagnostic Systems, Inc. | 1982-07-16 |
| K781017 | ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) | Icl Scientific | 1978-08-14 |
| K780335 | LAS-R HUMAN C1 ESTERASE INHIBITOR TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-03-22 |
Legacy Summary#
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FDA Review#
Decision Summary