HUMAN IGD KIT FOR USE ON SPAPLUS
FDA 510(k) clearance K092450 · decided 2009-12-28
Clearance details
- K-number
- K092450
- Device name
- HUMAN IGD KIT FOR USE ON SPAPLUS
- Applicant
- The Binding Site
- Decision
- Substantially Equivalent
- Date received
- 2009-08-10
- Decision date
- 2009-12-28
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- CZJ
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IGD DIAGNOSTIC TEST KITS (K051299) | The Binding Site, Ltd. | 2005-11-23 |
| SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT (K002561) | The Binding Site, Ltd. | 2000-10-26 |
| HUMAN IGD IMMUNOLOGICAL NL TEST KIT (K913671) | The Binding Site, Ltd. | 1991-12-02 |
| QM300 CALIBRATOR D PACK (K883001) | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-22 |
| TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 (K872834) | Helena Laboratories | 1987-08-12 |
| DETERM. SIZE 72 RADIAL-HUMAN IGD (K831956) | Kent Laboratories, Inc. | 1983-07-18 |
| LAS-R HUMAN IGD TEST (K772327) | Hyland Therapeutic Div., Travenol Laboratories | 1978-02-28 |
Recalls involving this device
No recalls on record reference this clearance.