FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARIES® Flu A/B & RSV Assay
K Number: K161220
·
Decision Aug 2, 2016
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
78
Applicant Total
15
Review Days
95
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Basic Information
- Device Name
- ARIES® Flu A/B & RSV Assay
- K Number
- K161220
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Luminex Corporation
- Date Received
- April 29, 2016
- Decision Date
- August 2, 2016
- Product Code
- OCC
- 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 |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | FDA class 2 | Microbiology |
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Other Clearances by Luminex Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex Assay | May 19, 2026 | Substantially Equivalent |
| 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 |