ABX PENTRA 60 HEMATOLOGY ANALYZER
FDA 510(k) clearance K992511 · decided 1999-10-15
Clearance details
- K-number
- K992511
- Device name
- ABX PENTRA 60 HEMATOLOGY ANALYZER
- Applicant
- Abx Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1999-07-27
- Decision date
- 1999-10-15
- Days to decision
- 80 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604 recall (Z-0039-04) | Beckman Coulter Inc | 2003-10-15 |