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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 K994045
Device Name PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
Applicant
Primus Corp.
7235 Central
Kansas City,  MO  64114
Applicant Contact JIM NOFFSINGER
Correspondent
Primus Corp.
7235 Central
Kansas City,  MO  64114
Correspondent Contact JIM NOFFSINGER
Regulation Number864.7470
Classification Product Code
LCP  
Date Received11/29/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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