FDA applicant

Immuno Pathology Labs

Walker, MI1 decision1982–19820 recalls

FDA records 1 decision for Immuno Pathology Labs (Walker, MI) in 1982: 1 510(k) clearance. All are in product code JHJ (Agglutination Method, Human Chorionic…). 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 chemistry panel, where it files most

How often FDA has decided Immuno Pathology Labs’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Immuno Pathology Labs since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Immuno Pathology Labs’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 “Immuno”

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

Immuno Concepts, Inc. 36 Immuno Nuclear Corp. 30 Immuno-Mycologics, Inc. 26 Immuno-Products Industries 12 Immuno Assay Corp. 10 Immuno-Diagnostic Products, Inc. 8 Immuno Concepts, N.A., Ltd. 4 Immuno Diagnostic Center, Inc. 3 Immuno-Diagnostic Laboratories 2 Immuno-U.S., Inc. 1

Immuno Pathology Labs

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Immuno”