HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
FDA 510(k) clearance K082129 · decided 2009-02-10
Clearance details
- K-number
- K082129
- Device name
- HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
- Applicant
- The Binding Site, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-29
- Decision date
- 2009-02-10
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- CFN
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Santa Monica, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buf recall (Z-0604-2019) | The Binding Site Group, Ltd. | 2018-12-13 |
| Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buf recall (Z-0477-2019) | The Binding Site Group, Ltd. | 2018-11-17 |