Medical Device Manufacturer · US , Carlsbad , CA

True Diagnostics, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2017

Recent clearances: VeriClear Digital Early Result Pregnancy Test, 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)

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - True Diagnostics, Inc. Chemistry ✕

2 devices

1-2 of 2

Cleared May 15, 2019

VeriClear Digital Early Result Pregnancy Test

Chemistry · 261d

Cleared Dec 22, 2017

TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early...

Chemistry · 149d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Jun 03, 2026