510(k) Report

FDA applicant

Molecular Diagnostics

Chicago, IL1 decision2002–20020 recalls

FDA records 1 decision for Molecular Diagnostics (Chicago, IL) in 2002: 1 510(k) clearance. All are in product code HHT (Spatula, Cervical, Cytological). Its devices cite 2 predicates, 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Molecular Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HHTSpatula, Cervical, Cytological1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K013258Inpath E2 CollectorMolecular Diagnostics · 20021cites it

What has FDA decided for it lately?

  • K013258Inpath E2 CollectorMolecular Diagnostics · 2002

The one decision as Molecular Diagnostics →

Other applicant names beginning “Molecular”

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

Molecular Biosystems, Inc. 4Molecular Devices Corp. 4Molecular Products, Ltd. 4Molecular Matrix, Inc. 1Molecular Technologies Corp. 1