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510(k) Data Aggregation
K Number
K973365Device Name
AIC - CHEK (HBAIC-I)
Manufacturer
EXPRESS-MED, INC.
Date Cleared
1998-06-15
(280 days)
Product Code
LCP
Regulation Number
864.7470Why did this record match?
Applicant Name (Manufacturer) :
EXPRESS-MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of Express-Med's A1c-EXPRESS is for the determination of percent of hemoglobin A1c in human whole blood samples. Clinically, Express-Med's A1c-EXPRESS is intended to be used as a measure of longterm glycemic control in patients with diabetes mellitus. This product will be available to patients through Point of Care offices.
Preferably, A1c-EXPRESS should be used in conjunction with other diabetes management tools, including consultation with health care professionals, goal-setting, education, exercise, diet, and, when prescribed, medication.
A1c-EXPRESS does not replace daily blood glucose monitoring.
There are no known contraindications.
The kit should be kept out of reach of children.
Device Description
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