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The FORA V12 No-Coding Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It also includes a speaking functionality to aid visually impaired persons. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in above systems can be used only during steady-state blood glucose conditions.

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The provided text is a 510(k) premarket notification letter from the FDA to TaiDoc Technology Corporation regarding their FORA V12 No-Coding Blood Glucose Monitoring System. It mainly discusses the substantial equivalence determination and regulatory requirements.

Crucially, this document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive summary of safety and effectiveness. These details would usually be part of the submission materials that led to this FDA letter, but they are not present in the letter itself.

Therefore, I cannot extract the requested information. The document focuses on regulatory approval rather than the technical and clinical data supporting that approval.

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