ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT

Assay, Glycosylated Hemoglobin

DIABETES TECHNOLOGIES, INC. (DTI)

The following data is part of a premarket notification filed by Diabetes Technologies, Inc. (dti) with the FDA for Accu-base Hemoglobin A1c Sample Collection Kit.

Pre-market Notification Details

Device IDK983172
510k NumberK983172
Device Name:ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
ClassificationAssay, Glycosylated Hemoglobin
Applicant DIABETES TECHNOLOGIES, INC. (DTI) 216 WEST JACKSON ST. Thomasville,  GA  31792
ContactArthur G Williams
CorrespondentArthur G Williams
DIABETES TECHNOLOGIES, INC. (DTI) 216 WEST JACKSON ST. Thomasville,  GA  31792
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-10
Decision Date1998-11-30
Summary:summary

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