FDA applicant

Opko Diagnostics, LLC

Woburn1 decision2019–20190 recalls

FDA records 1 decision for Opko Diagnostics, LLC (Woburn) in 2019: 1 original PMA approval. All are in product code MTF (Total, Prostate Specific Antigen (Noncomplexed…). 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 Opko Diagnostics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Opko Diagnostics, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Opko”

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

Opko Health, Inc. 2 Opko Instrumentation, Inc. 1

Opko Diagnostics, LLC

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Opko”