510(k) Report

FDA applicant

Litmus Concepts, Inc.

Front Royal, VA2 decisions1997–19970 recalls

FDA records 2 decisions for Litmus Concepts, Inc. (Front Royal, VA) in 1997: 2 510(k) clearances. Most are in product codes MJM (Dna Probe, Gardnerella Vaginalis) and CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative)). 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 Litmus Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Litmus Concepts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Litmus Concepts, Inc. 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?

  • MJMDna Probe, Gardnerella Vaginalis1decision
  • CENDye-Indicator, Ph (Urinary, Non-Quantitative)1decision

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K962718Femexam TestcardLitmus Concepts, Inc. · 19972cite it
  • K964015Indicard TestLitmus Concepts, Inc. · 19971cites it

What has FDA decided for it lately?

  • K964015Indicard TestLitmus Concepts, Inc. · 1997
  • K962718Femexam TestcardLitmus Concepts, Inc. · 1997

All 2 as Litmus Concepts, Inc. →