FDA applicant

Omega Medical Diagnostics

Mchenry, IL5 decisions1983–19830 recalls

FDA records 5 decisions for Omega Medical Diagnostics (Mchenry, IL) in 1983: 5 510(k) clearances. Most are in product codes PPM (General Purpose Reagent) and GIF (Diluent, Blood Cell). 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 Omega Medical Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omega Medical Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Omega Medical Diagnostics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Omega”

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

Omega Medical Electronics 21 Omega Medical Imaging, Inc. 15 Omega-Med Intl., Inc. 9 Omega Laboratories, Inc. 9 Omega Silicone, Inc. 5 Omega Universal Technologies, Ltd. 3 Omega Surgical Instruments, Inc. 3 Omega Medical Corp. 2 Omega Point Systems, LLC 1 Omega Mark-3 Pen Corp. 1 Omega Technologies, Inc. 1 Omega Critical Care Limited 1

Omega Medical Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Omega”