ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit— 510(k) K171441
Substantially EquivalentLuminex Corporation
FDA 510(k) clearance K171441 for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit, Substantially Equivalent on 2017-07-21. Applicant: Luminex Corporation.
Clearance details
- Applicant
- Luminex Corporation
- Product code
- Code OZN
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.