510(k) Report

FDA applicant

Savyon Diagnostics, Ltd.

Ashdod, IL5 decisions1991–19920 recalls

FDA records 5 decisions for Savyon Diagnostics, Ltd. (Ashdod, IL) from 1991 to 1992: 5 510(k) clearances. Most are in product codes LKH (Antisera, Immunoperoxidase, Chlamydia Spp.) and LJC (Enzyme Linked Immunoabsorbent Assay…). 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 Savyon Diagnostics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Savyon Diagnostics, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Savyon Diagnostics, Ltd.’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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