Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
FDA 510(k) clearance K152389 · decided 2015-12-18
Clearance details
- K-number
- K152389
- Device name
- Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
- Applicant
- The Binding Site Group , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-24
- Decision date
- 2015-12-18
- Days to decision
- 116 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 |
|---|---|---|
| HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS (K140686) | The Binding Site Group , Ltd. | 2014-08-06 |
Recalls involving this device
No recalls on record reference this clearance.