MEDONIC CA620/530 HEMATOLOGY ANALYZER
FDA 510(k) clearance K032214 · decided 2004-01-29
Clearance details
- K-number
- K032214
- Device name
- MEDONIC CA620/530 HEMATOLOGY ANALYZER
- Applicant
- Boule Medical AB
- Decision
- Substantially Equivalent
- Date received
- 2003-07-21
- Decision date
- 2004-01-29
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Plantation, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.