VIDAS CA 125 II ASSAY— 510(k) K080561
Substantially EquivalentbioMerieux, Inc.
FDA 510(k) clearance K080561 for VIDAS CA 125 II ASSAY, Substantially Equivalent on 2009-04-10. Applicant: bioMerieux, Inc..
Clearance details
- Applicant
- bioMerieux, Inc.
- Product code
- Code LTK
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.