510(k) K092450
- Device
- HUMAN IGD KIT FOR USE ON SPAPLUS
- Applicant
- THE BINDING SITE
- 510(k) number
- K092450
- Product code
- CZJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-28
- Date received
- 2009-08-10
- Regulation
- 866.5510
- Classification name
- Igd, 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
- JAY GELLER
- Address
- 12100 Wilshire Blvd. Suite 500 Los Angeles CA US 90025 90025
FDA Registration Numbers#
- 3012471076
- 3019906
- 1618982
- 9614373
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CZJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051299 | IGD DIAGNOSTIC TEST KITS | The Binding Site, Ltd. | 2005-11-23 |
| K002561 | SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | 2000-10-26 |
| K913671 | HUMAN IGD IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | 1991-12-02 |
| K883001 | QM300 CALIBRATOR D PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-22 |
| K872834 | TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 | Helena Laboratories | 1987-08-12 |
| K831956 | DETERM. SIZE 72 RADIAL-HUMAN IGD | Kent Laboratories, Inc. | 1983-07-18 |
| K772327 | LAS-R HUMAN IGD TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-02-28 |
Legacy Summary#
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FDA Review#
Decision Summary