510(k) Report

FDA applicant

American Dade

Mchenry, IL149 decisions1980–19874 recalls

FDA records 149 decisions for American Dade (Mchenry, IL) from 1980 to 1987: 149 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and GGP (Test, Qualitative And Quantitative Factor…). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for American Dade since 2007.

Recalls per year

1in 2013

2011: 12013: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — American Dade 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?

  • JJYMulti-Analyte Controls, All Kinds (Assayed)9decisions
  • GGPTest, Qualitative And Quantitative Factor Deficiency9decisions
  • JPKMixture, Hematology Quality Control5decisions
  • GIOTube, Collection, Capillary Blood5decisions
  • JIXCalibrator, Multi-Analyte Mixture4decisions
  • JITCalibrator, Secondary4decisions

Also: JJS (3), KHQ (3), GJS (3), CIG (3), JQW (3), LAN (2).

Who builds on its devices?

Later devices cite its devices 5 times; 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.

  • K850570Stratus HCG Fluorometric Enzyme ImmunoassayAmerican Dade · 19851cites it
  • K863594Actin FSL Activated PTT ReagentAmerican Dade · 19861cites it
  • K871977Dade Moni-Trol Chemistry Control/CalibratorAmerican Dade · 19871cites it
  • K860906Stratus Immunoassay Controls, Levels I, II, IiiAmerican Dade · 19861cites it
  • K812424CI-Trol Heparin Controls, Low/HighAmerican Dade · 19811cites it

What has FDA decided for it lately?

  • K873051Stratus (R) HFSH Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K873171Stratus (R) CK-MB Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K873052Stratus (R) HLH Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K872789Paramax Urine/CSF CalibratorAmerican Dade · 1987
  • K872195Data-FI Dimertest Latex AssayAmerican Dade · 1987
  • K872196Aqueous Blood Gas/Electrolyte Contr Lev I,II & IiiAmerican Dade · 1987
  • K871972Stratus Ige Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K871977Dade Moni-Trol Chemistry Control/CalibratorAmerican Dade · 1987

All 149 as American Dade →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K863594Dade (R) Actin (R) FSL Activated PTT Reagent. For use in the determination of the…Mar 11, 2013Class II
  • K863594Dade (R) Actin (R) FSL Activated PTT Reagent Product Usage: Liquid purified soy and…Dec 19, 2011
  • K811589Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time.…Sep 23, 2005
  • K872360Dade Fibrin (ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10EJun 21, 2005