Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
FDA 510(k) clearance K161854 · decided 2016-10-04
Clearance details
- K-number
- K161854
- Device name
- Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
- Applicant
- The Binding Site Group , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-07-06
- Decision date
- 2016-10-04
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PCN
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Edgbaston, 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 IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit (K172613) | The Binding Site Group , Ltd. | 2018-02-15 |
| HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT (K132555) | The Binding Site | 2013-12-20 |
Recalls involving this device
No recalls on record reference this clearance.