ID-TAG RESPIRATORY VIRAL PANEL— 510(k) DEN070013
UnknownLuminex Molecular Diagnostics, Inc.
FDA 510(k) clearance DEN070013 for ID-TAG RESPIRATORY VIRAL PANEL, Unknown on 2008-01-03. 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
- Unknown
- Clearance type
- Post-NSE
- Location
- Toronto, Ontario, 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)
- K193167 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
- 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)
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.