FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIAISON PLEX Gastrointestinal Flex Assay
K Number: K253722
·
Decision May 19, 2026
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
37
Applicant Total
15
Review Days
176
Basic Information
- Device Name
- LIAISON PLEX Gastrointestinal Flex Assay
- K Number
- K253722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3990
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Luminex Corporation
- Date Received
- November 24, 2025
- Decision Date
- May 19, 2026
- Product Code
- PCH
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | FDA class 2 | Microbiology |
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Other Clearances by Luminex Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay | Jun 6, 2025 | Substantially Equivalent |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture Assay | Apr 18, 2025 | Substantially Equivalent |
| K240627 | LIAISON PLEX Yeast Blood Culture Assay | Jun 4, 2024 | Substantially Equivalent |
| K233410 | LIAISON PLEX Respiratory Flex Assay | Mar 1, 2024 | Substantially Equivalent |
| K191742 | ARIES MRSA Assay | Sep 25, 2019 | Substantially Equivalent |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | Oct 30, 2017 | Substantially Equivalent |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit | Jul 21, 2017 | Substantially Equivalent |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | May 2, 2017 | Substantially Equivalent |
| K162772 | ARIES GBS Assay | Dec 23, 2016 | Substantially Equivalent |
| K161220 | ARIES® Flu A/B & RSV Assay | Aug 2, 2016 | Substantially Equivalent |