NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
FDA 510(k) clearance K231758 · decided 2024-03-11
Clearance details
- K-number
- K231758
- Device name
- NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-06-16
- Decision date
- 2024-03-11
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- QOF
- Device class
- 2
- Regulation number
- 866.3981
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.