510(k) Report

FDA applicant

Separation Technology, Inc.

Salt Lake City, UT2 decisions1989–19910 recalls

FDA records 2 decisions for Separation Technology, Inc. (Salt Lake City, UT) from 1989 to 1991: 2 510(k) clearances. All are in product code GKG (Centrifuge, Hematocrit). 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 Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Separation Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Separation Technology, 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 “Separation”

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