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True Diagnostics, Inc.

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

Total Devices2
Categories2
Latest Approval2019-05-15
TypeNumberDevice NameCodeDate
510(k) K182328 VeriClear Digital Early Result Pregnancy Test LCX 2019-05-15 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) JHI 2017-12-22 View