510(k) Report

FDA applicant

Sweden Diagnostics (Us), Inc.

Portage, MI1 decision2006–20061 recall

FDA records 1 decision for Sweden Diagnostics (Us), Inc. (Portage, MI) in 2006: 1 510(k) clearance. All are in product code NHX (Antibodies, Anti-Cyclic Citrullinated Peptide…). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, immunology panel, where it files most

How often FDA has decided Sweden Diagnostics (Us), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sweden Diagnostics (Us), Inc. since 2007.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sweden Diagnostics (Us), Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sweden Diagnostics (Us), 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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Which product codes does it file in?

  • NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K061165Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01Sweden Diagnostics (Us), Inc. · 20061cites it

What has FDA decided for it lately?

  • K061165Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01Sweden Diagnostics (Us), Inc. · 20061 recall

The one decision as Sweden Diagnostics (Us), Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K061165EliA Sample Diluent, Article number, 83-1023-01Jan 30, 2017Class II

Other applicant names beginning “Sweden”

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

Sweden & Martina S.P.A. 8Sweden Diagnostics (Germany) GmbH 8