True Diagnostics, Inc. is one of 13008 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
True Diagnostics, Inc. - FDA 510(k) Cleared Devices
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)
2
Total
2
Cleared
0
Denied
True Diagnostics, Inc. has 2 FDA 510(k) cleared medical devices. Based in Carlsbad, US.
Historical record: 2 cleared submissions from 2017 to 2019. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by True Diagnostics, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Biologics Consulting Group and Axteria Biomed Consulting, Inc..
FDA 510(k) Regulatory Record - True Diagnostics, Inc.
2 devices