ABX PENTRA 60C+ HEMATOLOGY ANALYZER
FDA 510(k) clearance K003677 · decided 2000-12-26
Clearance details
- K-number
- K003677
- Device name
- ABX PENTRA 60C+ HEMATOLOGY ANALYZER
- Applicant
- Abx Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2000-11-29
- Decision date
- 2000-12-26
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ABX Diagnostices Pentra 60C+ Hematology Analyzer recall (Z-1149-03) | ABX Diagnostics Inc | 2003-08-21 |
| AcT 5 diff Cap Pierce Hematology Analyzer 864.5220 Automated differential cell counter recall (Z-0570-03) | Beckman Coulter Inc | 2003-02-25 |