FDA applicant

Monobind

Costa Mesa, CA23 decisions1977–20180 recalls

FDA records 23 decisions for Monobind (Costa Mesa, CA) from 1977 to 2018: 23 510(k) clearances. Most are in product codes CDP (Radioimmunoassay, Total Triiodothyronine) and JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Monobind, Inc.”.

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 Monobind’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Monobind

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?