510(k) K982935— SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
Substantially EquivalentBeckman Coulter, Inc.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code KXT
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.