510(k) Report

FDA applicant

Separation Science Corp.

Walker, MI2 decisions1981–19820 recalls

FDA records 2 decisions for Separation Science Corp. (Walker, MI) from 1981 to 1982: 2 510(k) clearances. Most are in product codes KSE (Refrigerator, Freezer, Blood Storage) and KSQ (Device, Blood Mixing And Blood Weighing). 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 Separation Science Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Separation Science Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Separation”

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