ARIES GBS Assay— 510(k) K162772
Substantially EquivalentLuminex Corporation
FDA 510(k) clearance K162772 for ARIES GBS Assay, Substantially Equivalent on 2016-12-23. Applicant: Luminex Corporation.
Clearance details
- Applicant
- Luminex Corporation
- Product code
- Code NJR
- 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.