# Sigma Diagnostics, Inc.

- Location (FDA's records): St. Louis, MO
- FDA decisions: 164 (1984–2002): 164 510(k) clearances
- Product codes: JPA (8), LJG (7), CDQ (5), CIT (4), CJE (4), DAP (4), GJT (4), JJX (3), JIT (3), DLJ (3), GGN (3), CFR (3)
- Predicates its devices cite: 16 (3 its own); citations of its devices by later devices: 12 (3 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Trace America, Inc.: 5 (https://510kreport.com/company/trace-america)
- Trace Scientific, Ltd.: 4 (https://510kreport.com/company/trace-scientific)
- Wako Chemicals USA, Inc.: 1 (https://510kreport.com/company/wako-chemicals-usa)
- Pacific Hemostasis: 1 (https://510kreport.com/company/pacific-hemostasis)
- Bio-Rad: 1 (https://510kreport.com/company/bio-rad)
- Medical Diagnostic Technologies, Inc.: 1 (https://510kreport.com/company/medical-diagnostic-technologies)

## Firms that cite its devices most
- Biosafe Laboratories, Inc.: 2 (https://510kreport.com/company/biosafe-laboratories)
- Roche Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/roche-diagnostic-systems)
- Diazyme Laboratories: 1 (https://510kreport.com/company/diazyme-laboratories)
- Maine Standards Co.: 1 (https://510kreport.com/company/maine-standards)
- Trinity Biotech, Plc: 1 (https://510kreport.com/company/trinity-biotech)
- Polymer Technology Systems, Inc.: 1 (https://510kreport.com/company/polymer-technology-systems)
- Diagnostica Stago, Inc.: 1 (https://510kreport.com/company/diagnostica-stago)
- Binax, Inc.: 1 (https://510kreport.com/company/binax)

## Its most-cited devices
- K003329: Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217 (2001), cited by 2
- K021162: Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation Analyzer-Refurbished (2002), cited by 2
- K972041: EZ HDL Cholesterol Reagent (Procedure 354)/EZ HDL Calibrator (354-5) (1997), cited by 2
- K870012: Triglyceride (Gpo-Trinder) Reagent (1987), cited by 1
- K933934: Glucose-6-Phosphate Dehydrogenase Deficiency Screening Test Kit NO. 202-a (1995), cited by 1
- K863751: Multi-Analyte Lin-Trol (1986), cited by 1

## Recent decisions
- K021162: Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation Analyzer-Refurbished (Aug 30, 2002)
- K020109: Sigma Diagnostics Accuclot LA Control (Feb 6, 2002)
- K013549: Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971 (Dec 26, 2001)
- K013544: Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096 (Nov 15, 2001)
- K013545: Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221 (Nov 15, 2001)
- K012410: Infinity Hba Kit, Models 537-a, 537-B (Oct 26, 2001)
- K010652: Sigma Diagnostics Sigma-Cal, Model S2936 (Mar 30, 2001)
- K010158: Thrombomax-HS with Calcium, Model T6540 (Mar 22, 2001)

Source page: https://510kreport.com/company/sigma-diagnostics