510(k) Report

FDA applicant

Scandinavian Formulas, Inc.

Sellersville, PA1 decision2005–20050 recalls

FDA records 1 decision for Scandinavian Formulas, Inc. (Sellersville, PA) in 2005: 1 510(k) clearance. All are in product code LED (Stains, Chemical Solution). 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 Scandinavian Formulas, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scandinavian Formulas, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Scandinavian Formulas, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LEDStains, Chemical Solution1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051409SlivasureScandinavian Formulas, Inc. · 20051cites it

What has FDA decided for it lately?

  • K051409SlivasureScandinavian Formulas, Inc. · 2005

The one decision as Scandinavian Formulas, Inc. →

Other applicant names beginning “Scandinavian”

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

Scandinavian Health Limited 4Scandinavian Medical JW AB 1