PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
FDA 510(k) clearance K022200 · decided 2002-07-29
Clearance details
- K-number
- K022200
- Device name
- PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
- Applicant
- Abx Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2002-07-05
- Decision date
- 2002-07-29
- Days to decision
- 24 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 |
|---|---|---|
| ABX Pentra 120,120R,120DX, automated hematology analyzer recall (Z-1334-06) | ABX Diagnostics Inc | 2006-08-03 |
| PENTRA 120 and PENTRA 120 Retic Hematology Analyzer recall (Z-1342-04) | ABX Diagnostics Inc | 2004-08-13 |