510(k) Report

FDA applicant

Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)

Dun Laoghaire, IE1 decision2023–20230 recalls

FDA records 1 decision for Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) (Dun Laoghaire, IE) in 2023: 1 De Novo grant. All are in product code QYA (System For Detection Of Nucleic Acid From…). 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, microbiology panel, where it files most

How often FDA has decided Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Letsgetchecked Inc. (Formerly…’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

Which product codes does it file in?

  • QYASystem For Detection Of Nucleic Acid From Non-Viral Microorganism (S) Causing Stis Using…1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN200070Simple 2 TestLetsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) · 20231cites it

What has FDA decided for it lately?

  • DEN200070Simple 2 TestLetsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) · 2023

The one decision as Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) →