510(k) Report

FDA applicant

Diagnostica Stago, Inc.

Parisppany, NJ25 decisions2001–202612 recalls

FDA records 25 decisions for Diagnostica Stago, Inc. (Parisppany, NJ) from 2001 to 2026: 25 510(k) clearances. Most are in product codes JPA (System, Multipurpose For In Vitro Coagulation…) and GGN (Plasma, Coagulation Control). Its devices cite 28 predicates, 12 of them its own earlier devices. 12 recalls are linked to its devices.

FDA’s records also spell it “Diagnostica Stago S.A.S”, “Diagnostica Stago”, “Diagnostica Stago, Incorporated”, “Diagnostica-Stago”.

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 Diagnostica Stago, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 22009: 42010: 12011: 12013: 22014: 12015: 12016: 12022: 12023: 12026 (partial year): 2
2007high 4 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2026

2012: 12014: 12023: 32025: 52026 (partial year): 2
2007high 5 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Diagnostica Stago, Inc. 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?

  • JPASystem, Multipurpose For In Vitro Coagulation Studies8decisions
  • GGNPlasma, Coagulation Control3decisions
  • KFFAssay, Heparin3decisions
  • DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control2decisions
  • GGPTest, Qualitative And Quantitative Factor Deficiency2decisions
  • GGCControl, Plasma, Abnormal1decision

Also: GFO (1), GIR (1), LCO (1), GJS (1), JIX (1), JIT (1).

Whose devices does it build on?

Its devices cite 28 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 12 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.

  • K010350Sta -Calibrator HBPM/LMWH KitDiagnostica Stago, Inc. · 20012cite it
  • K003767Asserachrom Hpia Test KitDiagnostica Stago, Inc. · 20012cite it
  • K010963Sta-Liatest Free Protein S Test KitDiagnostica Stago, Inc. · 20012cite it
  • K082675Sta-R Evolution Automated Multi-Parametric AnalyzerDiagnostica Stago, Inc. · 20081cites it
  • K093001Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric AnalyzerDiagnostica Stago, Incorporated · 20091cites it
  • K061803Sta - Control LA 1+2Diagnostica Stago, Inc. · 20061cites it

What has FDA decided for it lately?

  • K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc. · 2026
  • K253658STA Satellite Max®Diagnostica Stago, Inc. · 2026
  • K212183STA R Max 3, STA Compact Max 3Diagnostica Stago S.A.S · 2023
  • K211485STA- NeoPTimalDiagnostica Stago S.A.S · 2022
  • K162227STA® - Liatest® D-DiDiagnostica Stago · 20162 recalls
  • K151867Sta R MaxDiagnostica Stago S.A.S · 20151 recall
  • K141144Sta Liatest D-DIDiagnostica Stago · 20141 recall
  • K120014Sta- Coag Control (N+Abn) PlusDiagnostica Stago, Inc. · 2013

All 17 as Diagnostica Stago, Inc. →All 3 as Diagnostica Stago S.A.S →All 2 as Diagnostica Stago →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K162227Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF…Feb 5, 2026Class II
  • K010963Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S…Feb 4, 2026Class II
  • K003767Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for…Dec 15, 2025Class II
  • K141144Product: STA Liatest D-Di; REF: 00515;Sep 12, 2025Class II
  • K082248STA Satellite. Product Code: All references. All software versions. The STA Satellite is…Jul 21, 2025Class II
  • K111822STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are…Jul 21, 2025Class II

Other applicant names beginning “Diagnostica”

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

Diagnostica, Inc. 12