XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)— 510(k) K140647
Substantially EquivalentLuminex Molecular Diagnostics, Inc.
FDA 510(k) clearance K140647 for XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP), Substantially Equivalent on 2014-10-24. Applicant: Luminex Molecular Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Product code
- Code PCH
- Device class
- Class 2
- Regulation
- 21 CFR 866.3990
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toronto, Ontario, CA
Recent devices under product code PCH
view allMore clearances from Luminex Molecular Diagnostics, Inc.
view all- K242613 — NxTAG® Respiratory Pathogen Panel
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.