Premier Resolution System— 510(k) K222635
Substantially EquivalentTrinity Biotech (Primus Corporation, Dba Trinity Biotech)
FDA 510(k) clearance K222635 for Premier Resolution System, Substantially Equivalent on 2023-08-04. Applicant: Trinity Biotech (Primus Corporation, Dba Trinity Biotech). Device class: 2.
Clearance details
- Applicant
- Trinity Biotech (Primus Corporation, Dba Trinity Biotech)
- Product code
- Code GKA
- Device class
- Class 2
- Regulation
- 21 CFR 864.7415
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kansas City, MO, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.