PX COULTER(R) CELL CONTROL— 510(k) K912133
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K912133 for PX COULTER(R) CELL CONTROL, Substantially Equivalent on 1991-07-17. Applicant: Coulter Electronics, Inc..
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code JPK
- Advisory panel
- Hematology
- 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.