XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX— 510(k) K121894
Substantially EquivalentLuminex Molecular Diagnostics, Inc.
FDA 510(k) clearance K121894 for XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX, Substantially Equivalent on 2013-03-21. 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, CA
Recent devices under product code PCH
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- 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.