Maverick RNP Assay and Maverick Diagnostic System— 510(k) K191085
Substantially EquivalentGenalyte, Inc.
FDA 510(k) clearance K191085 for Maverick RNP Assay and Maverick Diagnostic System, Substantially Equivalent on 2019-10-25. Applicant: Genalyte, Inc..
Clearance details
- Applicant
- Genalyte, Inc.
- Product code
- Code LKO
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.