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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 K992921
Device Name PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II
Applicant
Primus Corp.
P.O. Box 22599
Kansas City,  MO  64113
Applicant Contact JIMMIE K NOFFSINGER
Correspondent
Primus Corp.
P.O. Box 22599
Kansas City,  MO  64113
Correspondent Contact JIMMIE K NOFFSINGER
Regulation Number864.7470
Classification Product Code
LCP  
Date Received08/30/1999
Decision Date 11/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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