510(k) K905767— COULTER DART ALT (GPT) REAGENT
Substantially EquivalentCoulter Electronics, Inc.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code CKA
- 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.