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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 K062658
Device Name PRIMUS A1CARE ASSAY
Applicant
Primus Corp.
4231 E. 75th Ter.
Kansas City,  MO  64132
Applicant Contact BRITT EINSPAHR
Correspondent
Primus Corp.
4231 E. 75th Ter.
Kansas City,  MO  64132
Correspondent Contact BRITT EINSPAHR
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JJE  
Date Received09/06/2006
Decision Date 11/26/2007
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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