510(k) Report

FDA applicant

Ultra Quest Diagnostics, Inc.

Walker, MI3 decisions1984–19840 recalls

FDA records 3 decisions for Ultra Quest Diagnostics, Inc. (Walker, MI) in 1984: 3 510(k) clearances. Most are in product codes CEM (Electrode, Ion Specific, Potassium) and JGS (Electrode, Ion Specific, Sodium). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Ultra Quest Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ultra Quest Diagnostics, 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?

  • CEMElectrode, Ion Specific, Potassium2decisions
  • JGSElectrode, Ion Specific, Sodium1decision

What has FDA decided for it lately?

  • K843454Ultra Lyte Potassium Reagent KitUltra Quest Diagnostics, Inc. · 1984
  • K843453Ultra Lyte Sodium Reagent KitUltra Quest Diagnostics, Inc. · 1984
  • K842315Ultra Lyte Analyzer I 100Ultra Quest Diagnostics, Inc. · 1984

All 3 as Ultra Quest Diagnostics, Inc. →

Other applicant names beginning “Ultra”

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

Ultra Tan Intl. AB 2Ultra Seal Corporation 1Ultra Electronics Limited Precision Air & Land SY 1Ultra-Light Corp. 1