510(k) Report

FDA applicant

Northern Scientific, Inc.

Buffalo, NY3 decisions1983–19880 recalls

FDA records 3 decisions for Northern Scientific, Inc. (Buffalo, NY) from 1983 to 1988: 3 510(k) clearances. Most are in product codes LYX (Media, Corneal Storage) and KIT (Media And Components, Synthetic Cell And…). 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 Northern Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Northern Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Northern Scientific, 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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