ABX MICROS CRP 200, OPTION IM
FDA 510(k) clearance K053308 · decided 2005-12-29
Clearance details
- K-number
- K053308
- Device name
- ABX MICROS CRP 200, OPTION IM
- Applicant
- Horiba Abx
- Decision
- Substantially Equivalent
- Date received
- 2005-11-28
- Decision date
- 2005-12-29
- Days to decision
- 31 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 |
|---|---|---|
| Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Versio recall (Z-1173-2014) | Horiba Instruments, Inc dba Horiba Medical | 2014-03-11 |