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True Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories2
Latest FDA decision2019-05-15
TypeNumberDevice NameCodeDateActions
510(k) K182328 VeriClear Digital Early Result Pregnancy TestLCX2019-05-15 View
510(k) K172257 TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)JHI2017-12-22 View