FDA applicant

Innotron of Oregon, Inc.

Portland, OR28 decisions1980–19902 recalls

FDA records 28 decisions for Innotron of Oregon, Inc. (Portland, OR) from 1980 to 1990: 28 510(k) clearances. Most are in product codes DLJ (Calibrators, Drug Specific) and LBZ (Enzyme Immunoassay, Quinidine). 2 recalls are 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 of Oregon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Innotron of Oregon, Inc. since 2007.

Recalls per year

2in 2011

2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Innotron of Oregon, Inc.’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 Diagnostics 6

Innotron of Oregon, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Innotron”