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) by True Diagnostics, Inc. — Product Code JHI

K172257 is an FDA 510(k) premarket notification submitted by True Diagnostics, Inc. for the device "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)". The FDA issued a decision of Substantially Equivalent on December 22, 2017. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. True Diagnostics, Inc. has at least 1 other 510(k) clearance on record.