ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
FDA 510(k) clearance K171441 · decided 2017-07-21
Clearance details
- K-number
- K171441
- Device name
- ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
- Applicant
- Luminex Corporation
- Decision
- Substantially Equivalent
- Date received
- 2017-05-16
- Decision date
- 2017-07-21
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- OZN
- Device class
- 2
- Regulation number
- 866.3130
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059 recall (Z-2287-2019) | Luminex Corporation | 2019-08-15 |