DxH 520 Hematology Instrument
FDA 510(k) clearance K181475 · decided 2019-03-01
Clearance details
- K-number
- K181475
- Device name
- DxH 520 Hematology Instrument
- Applicant
- Beckman Coulter
- Decision
- Unknown
- Date received
- 2018-06-04
- Decision date
- 2019-03-01
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.