FDA applicant

True Diagnostics, Inc.

Carlsbad, CA2 decisions2017–20190 recalls

FDA records 2 decisions for True Diagnostics, Inc. (Carlsbad, CA) from 2017 to 2019: 2 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided True Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — True Diagnostics, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like True Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “True”

FDA records each applicant name separately; these may or may not be the same firm.

True Indicating, LLC 6 True Function Laboratory, Inc. 3 True Glove Factory 2 True Wearables, Inc. 1

True Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “True”