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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 K993131
Device Name NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
Applicant
Primus, Inc.
4747 Troost
Kansas City,  MO  64110
Applicant Contact JIMMIE K NOFFSINGER
Correspondent
Primus, Inc.
4747 Troost
Kansas City,  MO  64110
Correspondent Contact JIMMIE K NOFFSINGER
Regulation Number864.7470
Classification Product Code
LCP  
Date Received09/20/1999
Decision Date 05/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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