FDA applicant

Irvine Diagnostic Services

Mchenry, IL10 decisions1984–19840 recalls

FDA records 10 decisions for Irvine Diagnostic Services (Mchenry, IL) in 1984: 10 510(k) clearances. All are in product code JSF (Culture Media, Single Biochemical Test). 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 Irvine Diagnostic Services’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Irvine Diagnostic Services since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Irvine Diagnostic Services’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 “Irvine”

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

Irvine Scientific Sales Co., Inc. 40 Irvine Scientific 16 Irvine Biomedical, Inc. 13 Irvine Biomedical,Inc.(Ibi) 2 Irvine Biomedical, A St. Jude Medical Company 2

Irvine Diagnostic Services

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Irvine”