HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
FDA 510(k) clearance K132555 · decided 2013-12-20
Clearance details
- K-number
- K132555
- Device name
- HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
- Applicant
- The Binding Site
- Decision
- Substantially Equivalent
- Date received
- 2013-08-14
- Decision date
- 2013-12-20
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- PCN
- 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 IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit (K172613) | The Binding Site Group , Ltd. | 2018-02-15 |
| Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS (K161854) | The Binding Site Group , Ltd. | 2016-10-04 |
Recalls involving this device
No recalls on record reference this clearance.