FDA applicant

Meretek

Nashville, TN1 decision2000–20000 recalls

FDA records 1 decision for Meretek (Nashville, TN) in 2000: 1 510(k) clearance. All are in product code MSQ (Test, Urea (Breath Or Blood)). 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 Meretek’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Meretek since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Meretek’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 Diagnostics, Inc. 3

Meretek

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Meretek”