XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)— 510(k) K112199
Substantially EquivalentLuminex Molecular Diagnostics, Inc.
FDA 510(k) clearance K112199 for XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1), Substantially Equivalent on 2011-09-01. 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, 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 →
Recalls naming K112199
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 K112199.
Data sourced from openFDA. This site is unofficial and independent of the FDA.