FDA applicant

Ortho Diagnostics, Inc.

Mchenry, IL24 decisions1977–19800 recalls

FDA records 24 decisions for Ortho Diagnostics, Inc. (Mchenry, IL) from 1977 to 1980: 24 510(k) clearances. Most are in product codes KSG (Media, Potentiating For In Vitro Diagnostic Use) and JPK (Mixture, Hematology Quality Control). 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 Ortho Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ortho Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Ortho”

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

Ortho-Clinical Diagnostics, Inc. 152 Ortho Diagnostic Systems, Inc. 126 Ortho Development Corp. 64 Ortho Tec, LLC 22 Ortho Pharmaceutical Corp. 9 Ortho Source 9 Ortho Organizers, Inc. 8 Ortho Kinetics Corp. 7 Ortho Solutions Limited 6 Ortho Instruments 6 Ortho Kinematics, Inc. 6 Ortho Solutions UK, Ltd. 5

Ortho Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ortho”