Premier Resolution System
FDA 510(k) clearance K222635 · decided 2023-08-04
Clearance details
- K-number
- K222635
- Device name
- Premier Resolution System
- Applicant
- Trinity Biotech (Primus Corporation, Dba Trinity Biotech)
- Decision
- Substantially Equivalent
- Date received
- 2022-08-31
- Decision date
- 2023-08-04
- Days to decision
- 338 days
- Clearance type
- Traditional
- Product code
- GKA
- Device class
- 2
- Regulation number
- 864.7415
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Kansas City, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.