xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
FDA 510(k) clearance K183023 · decided 2018-11-30
Clearance details
- K-number
- K183023
- Device name
- xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-11-01
- Decision date
- 2018-11-30
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- PCH
- Device class
- 2
- Regulation number
- 866.3990
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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| QIAstat-Dx GI Panel 2 Mini B&V (K243813) | QIAGEN GmbH | 2025-01-08 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K242367) | Biofire Diagnostics, LLC | 2024-11-07 |
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Recalls involving this device
No recalls on record reference this clearance.