FDA applicant

Innotron Diagnostics

Walker, MI6 decisions1984–19850 recalls

FDA records 6 decisions for Innotron Diagnostics (Walker, MI) from 1984 to 1985: 6 510(k) clearances. Most are in product codes LCQ (Fluorescent Immunoassay Gentamicin) and LKT (Respiratory Syncytial Virus, Antigen…). 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 toxicology panel, where it files most

How often FDA has decided Innotron Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Innotron Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Innotron Diagnostics’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 “Innotron”

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

Innotron of Oregon, Inc. 28

Innotron Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Innotron”