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Has the TCI OvuLook™ been approved by the United States FDA?

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Has the TCI OvuLook™ been approved by the United States FDA?

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Yes, after five years of clinical studies, the TCI OvuLook™ was cleared by the FDA on December 5, 2001 under the name TCI OvuLook™ Life Long Ovulation Tester – 510(k) NO: K013323. You can visit the FDA’s website at www.fda.gov/cdrh/pdf/k013323.pdf, if you want to view this for yourself.

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