FDA applicant

Lab Vision Corp.

Fremont, CA2 decisions2006–20060 recalls

FDA records 2 decisions for Lab Vision Corp. (Fremont, CA) in 2006: 2 510(k) clearances. Most are in product codes MYA (Immunohistochemistry Antibody Assay, Estrogen…) and MXZ (Immunohistochemistry Assay, Antibody…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, hematology panel, where it files most

How often FDA has decided Lab Vision Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lab Vision Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Lab Vision Corp.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?