Atlas FDA

NxTAG® Respiratory Pathogen Panel

FDA 510(k) clearance K242613 · decided 2024-10-02

Clearance details

K-number
K242613
Device name
NxTAG® Respiratory Pathogen Panel
Applicant
Luminex Molecular Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2024-09-03
Decision date
2024-10-02
Days to decision
29 days
Clearance type
Special
Product code
OCC
Device class
2
Regulation number
866.3980
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Toronto, CA
Third-party review
No
Expedited review
No

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BioCode Respiratory Pathogen Panel (RPP) (K192485)Applied BioCode, Inc.2019-12-23
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software (K193167)Luminex Molecular Diagnostics, Inc.2019-12-11
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System (K191729)Roche Molecular Systems, Inc.2019-07-24
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Recalls involving this device

No recalls on record reference this clearance.