510(k) Report

FDA applicant

Marilyn L. Amick

Mchenry, IL3 decisions1978–19800 recalls

FDA records 3 decisions for Marilyn L. Amick (Mchenry, IL) from 1978 to 1980: 3 510(k) clearances. Most are in product codes KHG (Whole Blood Hemoglobin Determination) and JJQ (Colorimeter, Photometer, Spectrophotometer For…). 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, hematology panel, where it files most

How often FDA has decided Marilyn L. Amick’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Marilyn L. Amick since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Marilyn L. Amick 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?

  • KHGWhole Blood Hemoglobin Determination2decisions
  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use1decision

What has FDA decided for it lately?

  • K802568Hemoglobin ControlMarilyn L. Amick · 1980
  • K802569Abnormal Hemoglobin ControlMarilyn L. Amick · 1980
  • K781544Eppendorf PCP 6121Marilyn L. Amick · 1978

All 3 as Marilyn L. Amick →