PENTRA 80
FDA 510(k) clearance K024002 · decided 2003-01-03
Clearance details
- K-number
- K024002
- Device name
- PENTRA 80
- Applicant
- Abx Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2002-12-04
- Decision date
- 2003-01-03
- Days to decision
- 30 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Automated Differential Cell Counter recall (Z-0002-05) | ABX Diagnostics Inc | 2004-10-05 |
| Automated Differential Cell Counter recall (Z-0003-05) | ABX Diagnostics Inc | 2004-10-05 |