ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
FDA 510(k) clearance K170353 · decided 2017-11-01
Clearance details
- K-number
- K170353
- Device name
- ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
- Applicant
- HORIBA ABX SAS
- Decision
- Substantially Equivalent
- Date received
- 2017-02-03
- Decision date
- 2017-11-01
- Days to decision
- 271 days
- Clearance type
- Traditional
- 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
No recalls on record reference this clearance.