510(k) Report

FDA applicant

Jas Diagnostics, Inc.

Miami, FL20 decisions2000–20143 recalls

FDA records 20 decisions for Jas Diagnostics, Inc. (Miami, FL) from 2000 to 2014: 20 510(k) clearances. Most are in product codes CIG (Diazo Colorimetry, Bilirubin) and LBS (Ldl & Vldl Precipitation, Cholesterol Via…). Its devices cite 1 predicate, 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 Jas Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2008: 22014: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2014

2012: 12014: 2
2007high 2 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Jas Diagnostics, 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?

  • CIGDiazo Colorimetry, Bilirubin2decisions
  • LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1decision
  • CIXBromcresol Green Dye-Binding, Albumin1decision
  • KHSEnzymatic, Carbon-Dioxide1decision
  • CJYAzo Dye, Calcium1decision
  • CITNadh Oxidation/Nad Reduction, Ast/Sgot1decision

Also: KNK (1), CFR (1), JJE (1), LCP (1), CEO (1), JGJ (1).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K011900Glucose (Hexokinase)Jas Diagnostics, Inc. · 20011cites it
  • K003247CreatinineJas Diagnostics, Inc. · 20001cites it

What has FDA decided for it lately?

  • K130915XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent PackJas Diagnostics, Inc. · 2014
  • K080623Cholesterol Oxidase Jase, and Glycerol Inase Triglycerides, Model NAJas Diagnostics, Inc. · 2008
  • K080618Direct HBA1C, Fructosamine, Glucose Oxidase LiquidJas Diagnostics, Inc. · 2008
  • K022519LDL Cholesterol (Automated)Jas Diagnostics, Inc. · 20021 recall
  • K021671Jas HDL Cholesterol (Automated) ReagentJas Diagnostics, Inc. · 2002
  • K020454Chemistry CalibratorJas Diagnostics, Inc. · 2002
  • K020282Jas Amylase Liquid ReagentJas Diagnostics, Inc. · 2002
  • K013912Creatine Kinase (CK-Nac)Jas Diagnostics, Inc. · 2002

All 20 as Jas Diagnostics, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K011900Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of…Oct 23, 2014Class II
  • K011900Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose…Apr 7, 2014Class II
  • K022519BS-200 Chemistry Analyzer Designed for clinical laboratory use.Nov 28, 2012Class II