510(k) Report

FDA applicant

Meso Scale Diagnostics, LLC

Rockville, MD1 decision2018–20180 recalls

FDA records 1 decision for Meso Scale Diagnostics, LLC (Rockville, MD) in 2018: 1 510(k) clearance. All are in product code DCN (System, Test, C-Reactive Protein). Its devices cite 1 predicate, 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, immunology panel, where it files most

How often FDA has decided Meso Scale Diagnostics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Meso Scale Diagnostics, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Meso Scale Diagnostics, LLC’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?

  • DCNSystem, Test, C-Reactive Protein1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC · 2018

The one decision as Meso Scale Diagnostics, LLC →