510(k) Report

FDA applicant

Royal Scientific, Inc.

Mchenry, IL1 decision1978–19780 recalls

FDA records 1 decision for Royal Scientific, Inc. (Mchenry, IL) in 1978: 1 510(k) clearance. All are in product code JRW (Antisera, Fluorescent, B. Parapertussis). 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 Royal Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Royal Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Royal Scientific, 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?

  • JRWAntisera, Fluorescent, B. Parapertussis1decision

What has FDA decided for it lately?

  • K780713Culture SwabRoyal Scientific, Inc. · 1978

The one decision as Royal Scientific, Inc. →

Other applicant names beginning “Royal”

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

Royal American Industries, Inc. 2Royal Enterprises Manufacturing, Inc. 2Royal Oak Medical Devices 2Royal Precision Plastics, Inc. 1Royal King Infant Products Co., Ltd. 1Royal Flash Enterprise Co., Ltd. 1Royal Industries (Thailand) Public Co., Ltd. 1Royal Shine Enterprises, Ltd. 1Royal Dental Lab 1Royal Plastic Sarl 1Royal Pacific Intl. Trade, Inc. 1