Medical Device Manufacturer · US , Carlsbad , CA

True Diagnostics, Inc.

2 submissions · 2 cleared · Since 2017

Total

Cleared

Denied

True Diagnostics, Inc. — FDA 510(k) Submissions

True Diagnostics, Inc. has submitted 2 FDA 510(k) premarket notifications since 2017, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Kit, Test, Pregnancy, Hcg, Over The Counter, Visual, Pregnancy Hcg, Prescription Use . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

VeriClear Digital Early Result Pregnancy Test

K182328 · LCX Kit, Test, Pregnancy,... · Chemistry

May 2019 261d

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)

K172257 · JHI Visual, Pregnancy Hcg,... · Chemistry

Dec 2017 149d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

True Diagnostics, Inc.

True Diagnostics, Inc. — FDA 510(k) Submissions

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