Atlas FDA

NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software

FDA 510(k) clearance K193167 · decided 2019-12-11

Clearance details

K-number
K193167
Device name
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
Applicant
Luminex Molecular Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2019-11-15
Decision date
2019-12-11
Days to decision
26 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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Recalls involving this device

RecordFirmDate
NxTAG Respiratory Pathogen Panel, REF: I051C0447 recall (Z-0042-2025)Luminex Molecular Diagnostics Inc2024-10-09