K851942
Substantially EquivalentCOULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY
- Applicant
- Coulter Electronics, Inc.
- Product code
- JJY
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.