510(k) Report

FDA applicant

Sigma Diagnostics, Inc.

St. Louis, MO164 decisions1984–20022 recalls

FDA records 164 decisions for Sigma Diagnostics, Inc. (St. Louis, MO) from 1984 to 2002: 164 510(k) clearances. Most are in product codes JPA (System, Multipurpose For In Vitro Coagulation…) and LJG (Quality Control Slides). Its devices cite 16 predicates, 3 of them its own earlier devices. 2 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 Sigma Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sigma Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sigma Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JPASystem, Multipurpose For In Vitro Coagulation Studies8decisions
  • LJGQuality Control Slides7decisions
  • CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen5decisions
  • CITNadh Oxidation/Nad Reduction, Ast/Sgot4decisions
  • CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes4decisions
  • DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control4decisions

Also: GJT (4), JJX (3), JIT (3), DLJ (3), GGN (3), CFR (3).

Whose devices does it build on?

Its devices cite 16 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 3 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.

  • K003329Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217Sigma Diagnostics, Inc. · 20012cite it
  • K021162Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation…Sigma Diagnostics, Inc. · 20022cite it
  • K972041EZ HDL Cholesterol Reagent (Procedure 354)/EZ HDL Calibrator (354-5)Sigma Diagnostics, Inc. · 19972cite it
  • K870012Triglyceride (Gpo-Trinder) ReagentSigma Diagnostics, Inc. · 19871cites it
  • K933934Glucose-6-Phosphate Dehydrogenase Deficiency Screening Test Kit NO. 202-aSigma Diagnostics, Inc. · 19951cites it
  • K863751Multi-Analyte Lin-TrolSigma Diagnostics, Inc. · 19861cites it

What has FDA decided for it lately?

  • K021162Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation…Sigma Diagnostics, Inc. · 2002
  • K020109Sigma Diagnostics Accuclot LA ControlSigma Diagnostics, Inc. · 2002
  • K013549Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971Sigma Diagnostics, Inc. · 2001
  • K013544Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096Sigma Diagnostics, Inc. · 2001
  • K013545Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221Sigma Diagnostics, Inc. · 2001
  • K012410Infinity Hba Kit, Models 537-a, 537-BSigma Diagnostics, Inc. · 2001
  • K010652Sigma Diagnostics Sigma-Cal, Model S2936Sigma Diagnostics, Inc. · 2001
  • K010158Thrombomax-HS with Calcium, Model T6540Sigma Diagnostics, Inc. · 2001

All 164 as Sigma Diagnostics, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K871152Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K…May 27, 2005
  • K972796AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of…Oct 27, 2004

Other applicant names beginning “Sigma”

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

Sigma Chemical Co. 231Sigma Medical, Inc. 13Sigma 6Sigma Medical Supplies Corp. 5Sigma Intl. 3Sigma Cell Culture Reagents 2Sigma Scientific Services, LLC 1Sigma Teleproducts, Inc. 1Sigma Biomedics, Inc. 1Sigma Vision, Inc. 1Sigma Intl. General Medical Apparatus, Inc. 1Sigma-Brillen 1