510(k) Report

FDA applicant

Wallac OY

Turku, FI24 decisions1992–20147 recalls

FDA records 24 decisions for Wallac OY (Turku, FI) from 1992 to 2014: 22 510(k) clearances and 2 De Novo grants. Most are in product codes JLX (Radioimmunoassay, 17-Hydroxyprogesterone) and CGZ (Electrode, Ion-Specific, Chloride). Its devices cite 12 predicates, 5 of them its own earlier devices. 7 recalls are linked to its devices.

FDA’s records also spell it “Wallac, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Wallac OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2008: 22009: 12010: 12013: 12014: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2012: 32016: 32017: 1
2007high 3 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JLXRadioimmunoassay, 17-Hydroxyprogesterone5decisions
  • CGZElectrode, Ion-Specific, Chloride4decisions
  • CDZRadioimmunoassay, Testosterones And Dihydrotestosterone2decisions
  • NAKSystem, Test, Biotinidase2decisions
  • PJISevere Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System1decision
  • CGIRadioimmunoassay, Estriol1decision

Also: KXT (1), JIA (1), JLW (1), CDX (1), CFL (1), KHO (1).

Whose devices does it build on?

Its devices cite 12 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 5 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.

  • K003668Autodelfia Neonatal Irt Kit, Model B005-112Wallac OY · 20013cite it
  • K042425Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY · 20043cite it
  • K935047Auto DelfiaWallac OY · 19942cite it
  • DEN140010Perkinelmer Enlite Neonatal Trec Test SystemWallac OY · 20141cites it
  • K071649Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110BWallac OY · 20081cites it
  • K943416Delfia Neonatal Thyroxine KitWallac OY · 19951cites it

What has FDA decided for it lately?

  • DEN140010Perkinelmer Enlite Neonatal Trec Test SystemWallac OY · 2014
  • K131284GSP Neonatal Biotinidase KitWallac OY · 2013
  • K100682GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001UWallac OY · 2010
  • K081922Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY · 2009
  • K071649Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110BWallac OY · 20083 recalls
  • K070889Autodelfia Neonatal Irt L Kit, Model B022-112Wallac OY · 2008
  • K050709Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367Wallac OY · 20061 recall
  • K050960Modification to: Autodelfia Neonatal 17A-OH-Progesterone L KitWallac OY · 2005

All 22 as Wallac OY →All 2 as Wallac, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K050709Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer…May 15, 2017Class II
  • K935047DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100…Dec 21, 2016Class III
  • K935047Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number…Dec 21, 2016Class III
  • K935047AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110…Dec 21, 2016Class III
  • K071649NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended…Nov 26, 2012Class II
  • K071649DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010Nov 26, 2012Class II

Other applicant names beginning “Wallac”

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

Wallac Oy, A Subsidiary of Perkinelmer, Inc. 4Wallac Oy, Subsidiary of Perkinelmer 2