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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 K983172
Device Name ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
Applicant
Diabetes Technologies, Inc. (Dti)
216 W. Jackson St.
Thomasville,  GA  31792
Applicant Contact ARTHUR G WILLIAMS
Correspondent
Diabetes Technologies, Inc. (Dti)
216 W. Jackson St.
Thomasville,  GA  31792
Correspondent Contact ARTHUR G WILLIAMS
Regulation Number864.7470
Classification Product Code
LCP  
Date Received09/10/1998
Decision Date 11/30/1998
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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