510(k) Report

FDA applicant

Mct Medical, Inc.

Shoreview, MN3 decisions1986–19880 recalls

FDA records 3 decisions for Mct Medical, Inc. (Shoreview, MN) from 1986 to 1988: 3 510(k) clearances. Most are in product codes EXY (Uroflowmeter) and LQL (Gram Positive Identification Panel). 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 Mct Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mct Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mct Medical, 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?

  • EXYUroflowmeter1decision
  • LQLGram Positive Identification Panel1decision
  • LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation1decision

What has FDA decided for it lately?

  • K880504MCT Medical Browne Uroscan UrodynamicMct Medical, Inc. · 1988
  • K874606Cathra Gram Positive ScreenMct Medical, Inc. · 1988
  • K861958ReplianalyzerMct Medical, Inc. · 1986

All 3 as Mct Medical, Inc. →