NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software— 510(k) K193167
Substantially EquivalentLuminex Molecular Diagnostics, Inc.
FDA 510(k) clearance K193167 for NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software, Substantially Equivalent on 2019-12-11. Applicant: Luminex Molecular Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Product code
- Code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Toronto, CA
Recent devices under product code OCC
view allMore clearances from Luminex Molecular Diagnostics, Inc.
view all- K231758 — NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
- K191161 — xTAG Gastrointestinal Pathogen Panel (GPP)
- K191160 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
- K183023 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
- K183030 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
Adverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K193167
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193167.
Data sourced from openFDA. This site is unofficial and independent of the FDA.