FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
FDA 510(k) clearance K062372 · decided 2007-06-21
Clearance details
- K-number
- K062372
- Device name
- FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
- Applicant
- The Binding Site, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-14
- Decision date
- 2007-06-21
- Days to decision
- 311 days
- Clearance type
- Traditional
- Product code
- DFH
- Device class
- 2
- Regulation number
- 866.5550
- 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 |
|---|---|---|
| Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and mon recall (Z-1050-2017) | The Binding Site Group, Ltd. | 2017-01-19 |
| Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelit recall (Z-1053-2017) | The Binding Site Group, Ltd. | 2017-01-19 |