510(k) Report

FDA applicant

Stanbio Laboratory

Mchenry, IL47 decisions1977–20093 recalls

FDA records 47 decisions for Stanbio Laboratory (Mchenry, IL) from 1977 to 2009: 47 510(k) clearances. Most are in product codes JHJ (Agglutination Method, Human Chorionic…) and GKR (System, Hemoglobin, Automated). Its devices cite 6 predicates, 0 of them its own earlier devices. 3 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 Stanbio Laboratory’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 12009: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2018

2011: 12018: 2
2007high 2 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Stanbio Laboratory 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?

  • JHJAgglutination Method, Human Chorionic Gonadotropin4decisions
  • GKRSystem, Hemoglobin, Automated3decisions
  • JIYPhotometric Method, Iron (Non-Heme)2decisions
  • CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides2decisions
  • LDPColorimetry, Acetaminophen2decisions
  • DHRSystem, Test, Rheumatoid Factor1decision

Also: CIT (1), KNK (1), CDL (1), DCK (1), DIF (1), CKA (1).

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K081719Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemStanbio Laboratory · 20082cite it
  • K042169Stanbio Laboratory Sirrus Clinical Chemistry AnalyzerStanbio Laboratory · 20051cites it
  • K032482Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemStanbio Laboratory · 20031cites it
  • K050283Creatinine LiquicolorStanbio Laboratory · 20051cites it

What has FDA decided for it lately?

  • K090093Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement SystemStanbio Laboratory · 2009
  • K081719Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemStanbio Laboratory · 20081 recall
  • K050266Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorStanbio Laboratory · 2005
  • K050283Creatinine LiquicolorStanbio Laboratory · 2005
  • K042169Stanbio Laboratory Sirrus Clinical Chemistry AnalyzerStanbio Laboratory · 2005
  • K041155Wide Range C-Reactive Protein (WR CRP) AssayStanbio Laboratory · 2004
  • K032936Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL Cholesterol CalibratorStanbio Laboratory · 2004
  • K032932Direct HDL-Cholesterol Liquid Color; Direct HDL/LDL-Cholesterol CalibratorStanbio Laboratory · 2004

All 47 as Stanbio Laboratory →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K974370RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100…Feb 13, 2018Class II
  • K081719Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name…Feb 8, 2018Class II
  • K972155Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two…Oct 19, 2011Class III