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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 K013465
Device Name ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
Applicant
DIABETES TECHNOLOGIES, INC.
216 WEST JACKSON ST.
THOMASVILLE,  GA  31792
Applicant Contact ARTHUR G WILLIAMS
Correspondent
DIABETES TECHNOLOGIES, INC.
216 WEST JACKSON ST.
THOMASVILLE,  GA  31792
Correspondent Contact ARTHUR G WILLIAMS
Regulation Number864.7470
Classification Product Code
LCP  
Date Received10/18/2001
Decision Date 01/22/2002
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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