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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 K896582
Device Name DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)
Applicant
PRIMUS, INC.
4747 TROOST
KANSAS CITY,  MO  64110
Applicant Contact JACE REXROAD
Correspondent
PRIMUS, INC.
4747 TROOST
KANSAS CITY,  MO  64110
Correspondent Contact JACE REXROAD
Regulation Number864.7470
Classification Product Code
LCP  
Date Received11/17/1989
Decision Date 06/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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