PREMIER HB9210 HBA1C ANALYZER— 510(k) K112015
Substantially EquivalentPrimus Corporation Dba Trinity Biotech
FDA 510(k) clearance K112015 for PREMIER HB9210 HBA1C ANALYZER, Substantially Equivalent on 2011-11-22. Applicant: Primus Corporation Dba Trinity Biotech.
Clearance details
- Applicant
- Primus Corporation Dba Trinity Biotech
- Product code
- Code LCP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kansas City, MO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.