Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
FDA 510(k) clearance K160819 · decided 2016-06-16
Clearance details
- K-number
- K160819
- Device name
- Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
- Applicant
- The Binding Site Group , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-24
- Decision date
- 2016-06-16
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- OPX
- 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 |
|---|---|---|
| Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS (K151759) | The Binding Site Group , Ltd. | 2015-11-06 |
| HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII (K140105) | The Binding Site | 2014-03-18 |
Recalls involving this device
No recalls on record reference this clearance.