BOND MMR Antibody Panel
FDA 510(k) clearance K213348 · decided 2023-02-21
Clearance details
- K-number
- K213348
- Device name
- BOND MMR Antibody Panel
- Applicant
- Leica Biosystems Newcastle, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-10-08
- Decision date
- 2023-02-21
- Days to decision
- 501 days
- Clearance type
- Traditional
- Product code
- PZJ
- Device class
- 2
- Regulation number
- 864.1866
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Newcastle Upon Tyne, GB
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Idylla MSI Test (K211181) | Biocartis NV | 2023-02-27 |
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Recalls involving this device
No recalls on record reference this clearance.