COULTER POSITIVE CONTROL CELLS— 510(k) K894651
Substantially EquivalentCoulter Corp.
FDA 510(k) clearance K894651 for COULTER POSITIVE CONTROL CELLS, Substantially Equivalent on 1989-09-13. Applicant: Coulter Corp.. Device class: 2.
Clearance details
- Applicant
- Coulter Corp.
- Product code
- Code GGL
- Device class
- Class 2
- Regulation
- 21 CFR 864.8625
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.