ABX PENTRA DX 120: OPTION SPS EVOLUTION
FDA 510(k) clearance K050719 · decided 2005-04-26
Clearance details
- K-number
- K050719
- Device name
- ABX PENTRA DX 120: OPTION SPS EVOLUTION
- Applicant
- Horiba Abx
- Decision
- Substantially Equivalent
- Date received
- 2005-03-21
- Decision date
- 2005-04-26
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Montpellier, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ABX Pentra 120,120R,120DX, automated hematology analyzer recall (Z-1334-06) | ABX Diagnostics Inc | 2006-08-03 |