FDA applicant

Diagnostic Chemicals, Ltd. (Usa)

Canada77 decisions1984–20021 recall

FDA records 77 decisions for Diagnostic Chemicals, Ltd. (Usa) (Canada) from 1984 to 2002: 77 510(k) clearances. Most are in product codes CIG (Diazo Colorimetry, Bilirubin) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). 1 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 chemistry panel, where it files most

How often FDA has decided Diagnostic Chemicals, Ltd. (Usa)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diagnostic Chemicals, Ltd. (Usa) since 2007.

Recalls per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Diagnostic Chemicals, Ltd. (Usa) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Diagnostic Chemicals, Ltd. (Usa)’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 “Diagnostic”

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

Diagnostic Products Corp. 324 Diagnostic Systems Laboratories, Inc. 94 Diagnostic Reagents, Inc. 66 Diagnostic Chemicals, Ltd. 66 Diagnostic Hybrids, Inc. 37 Diagnostic Technology, Inc. 28 Diagnostic Solutions, Inc. 26 Diagnostic Ultrasound Corp. 16 Diagnostic Systems 14 Diagnostic Reagent Tech. 10 Diagnostic Specialties 8 Diagnostic Monitoring Software 5

Diagnostic Chemicals, Ltd. (Usa)

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Diagnostic”