# Sigma Chemical Co.

- Location (FDA's records): St. Louis, MO
- FDA decisions: 231 (1976–1994): 231 510(k) clearances
- Product codes: KIT (87), GGP (9), GJT (8), JFL (4), KIP (4), CHH (4), GKZ (4), GGN (3), JIX (3), GHD (3), HYB (3), CGS (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 11 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Precision Biologicals, Inc.: 2 (https://510kreport.com/company/precision-biologicals)
- Array Medical, Inc.: 2 (https://510kreport.com/company/array-medical)
- Universal Reagents, Inc.: 1 (https://510kreport.com/company/universal-reagents)
- Medisense, Inc.: 1 (https://510kreport.com/company/medisense)
- Bayer Diagnostics Corp.: 1 (https://510kreport.com/company/bayer-diagnostics)
- Innovative Bioceramix, Inc.: 1 (https://510kreport.com/company/innovative-bioceramix)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)
- Precision Biologic: 1 (https://510kreport.com/company/precision-biologic)

## Its most-cited devices
- K790211: Dehydrogenose, Glucose Phosphate (1979), cited by 1
- K832236: Sigma Procedure #550 Determ. Bilirub (1983), cited by 1
- K900906: Factor II Deficient Plasma (1990), cited by 1
- K760332: Sigma Ammonia Reagent (1976), cited by 1
- K843310: Factor X Deficient Plasma, Blod Human (1984), cited by 1
- K822733: Sigma Reagent System NO. 885 (1982), cited by 1

## Recent decisions
- K933694: Sigma Glucose Reagent (Nov 4, 1994)
- K933678: Sigma Calcium Reagent (Mar 11, 1994)
- K933696: Sigma Electrolyte Reference Reagent (Jan 3, 1994)
- K933691: Sigma CO2 Alkaline Buffer Reagent (Dec 17, 1993)
- K933679: Sigma Bun Reagent (Dec 17, 1993)
- K933703: Sigma Wash Concentrate Solution (Dec 10, 1993)
- K933692: Sigma CO2 Acid Reagent (Dec 9, 1993)
- K933695: Sigma Electrolyte Buffer (Oct 22, 1993)

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