PREMIER HB9210 HBA1C ANALYZER— 510(k) K112015

Name: FDA 510(k) clearance K112015
Creator: U.S. Food and Drug Administration
Published: 2011-11-22

Substantially Equivalent

Primus 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. Device class: 2.

Clearance details

Applicant: Primus Corporation Dba Trinity Biotech
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2011-07-13
Decision date: 2011-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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