FDA applicant

Meretek Diagnostics, Inc.

Nashville, TN3 decisions1996–20021 recall

FDA records 3 decisions for Meretek Diagnostics, Inc. (Nashville, TN) from 1996 to 2002: 3 510(k) clearances. Most are in product codes MSQ (Test, Urea (Breath Or Blood)) and LYR (Helicobacter Pylori). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 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 Meretek Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Meretek Diagnostics, Inc. since 2007.

Recalls per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Meretek Diagnostics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Meretek 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 “Meretek”

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

Meretek 1

Meretek Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Meretek”