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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K112015
Device Name PREMIER HB9210 HBA1C ANALYZER
Applicant
Primus Corporation Dba Trinity Biotech
4231 E. 75th Ter.
Kansas City,  MO  64132
Applicant Contact BRITT EINSPAHR
Correspondent
Primus Corporation Dba Trinity Biotech
4231 E. 75th Ter.
Kansas City,  MO  64132
Correspondent Contact BRITT EINSPAHR
Regulation Number864.7470
Classification Product Code
LCP  
Date Received07/13/2011
Decision Date 11/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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