K951631
Substantially EquivalentDIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
- Applicant
- Bayer Corp.
- Product code
- LFM
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.