HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
FDA 510(k) clearance K140686 · decided 2014-08-06
Clearance details
- K-number
- K140686
- Device name
- HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
- Applicant
- The Binding Site Group , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-03-19
- Decision date
- 2014-08-06
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- PDE
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Birmingham, GB
- 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 |
|---|---|---|
| Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit (K152389) | The Binding Site Group , Ltd. | 2015-12-18 |
Recalls involving this device
No recalls on record reference this clearance.