FDA applicant

Omega Laboratories, Inc.

Mogadore, OH9 decisions2010–20150 recalls

FDA records 9 decisions for Omega Laboratories, Inc. (Mogadore, OH) from 2010 to 2015: 9 510(k) clearances. Most are in product codes DIO (Enzyme Immunoassay, Cocaine And Cocaine…) and DJG (Enzyme Immunoassay, Opiates). Its devices cite 11 predicates, 4 of them its own earlier devices. 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 toxicology panel, where it files most

How often FDA has decided Omega Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2010high 2 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Omega Laboratories, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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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 Medical Diagnostics 5 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 Laboratories, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Omega”