510(k) Report

FDA applicant

American Diagnostica, Inc.

Greenwich, CT10 decisions1994–20084 recalls

FDA records 10 decisions for American Diagnostica, Inc. (Greenwich, CT) from 1994 to 2008: 10 510(k) clearances. Most are in product codes GGP (Test, Qualitative And Quantitative Factor…) and KFF (Assay, Heparin). Its devices cite 8 predicates, 1 of them its own earlier devices. 4 recalls are 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 American Diagnostica, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2012

2007: 12010: 12012: 2
2007high 2 (2012) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like American Diagnostica, 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?

  • GGPTest, Qualitative And Quantitative Factor Deficiency4decisions
  • KFFAssay, Heparin2decisions
  • DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control1decision
  • GIRReagent, Russel Viper Venom1decision
  • GIZPlasma, Control, Normal1decision
  • GJSTest, Time, Prothrombin1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K935254Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control PlasmaAmerican Diagnostica, Inc. · 19942cite it
  • K940490DV Test and DVV ConfirmAmerican Diagnostica, Inc. · 19951cites it

What has FDA decided for it lately?

  • K080069DimertestAmerican Diagnostica, Inc. · 2008
  • K063323Spectrolyse Pai-1, Model 101201American Diagnostica, Inc. · 20072 recalls
  • K052124Acticlot, Model 824American Diagnostica, Inc. · 20051 recall
  • K013637Actichrome Heparin (Anti-Fiia)American Diagnostica, Inc. · 2002
  • K013492Imubind Tpa Elisa, Model 860American Diagnostica, Inc. · 2002
  • K013318Actichrome Heparin (Anti-Fxa), Model 832American Diagnostica, Inc. · 2002
  • K013168Imubind Plasma Pai-1 Elisa,Model 822American Diagnostica, Inc. · 20021 recall
  • K012386Acticlot Protein S, Model 843LAmerican Diagnostica, Inc. · 2001

All 10 as American Diagnostica, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K063323Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative…Oct 24, 2012Class II
  • K063323Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of…Aug 28, 2012Class II
  • K013168REF 822 IMUBIND (R) Plasma PAI-1 ELISA The intended use: Product is an enzyme-linked…Mar 5, 2010
  • K052124American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnosticFeb 28, 2007