K011920
Substantially EquivalentEMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
- Applicant
- Syva Co., Dade Behring, Inc.
- Product code
- KXT
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cupertino, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.