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51O(k) Summary 040 - accessdata.fda.gov
The One Touch Ultra Control Solution verifies the performance of the One Touch Ultra Blood Glucose. Test Strips. Intended Use. The InDuo Blood Glucose Meter is
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26 CFR 48.4191-2 - Taxable medical device.
The blood glucose monitors and test strips are included in the FDAs online IVD Home Use Lab Tests (Over-the-Counter Tests) database. Therefore, the blood
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
The enzyme on the test strip, an FAD-dependent glucose dehydrogenase (GDH) expressed in. Aspergillus Oryzae, converts the glucose in the blood to gluconolactone
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