# Helix Diagnostics, Inc.

- Location (FDA's records): West Sacramento, CA
- FDA decisions: 15 (1991–2000): 15 510(k) clearances
- Product codes: LLL (6), LJM (3), LKJ (2), LRM (2), LKO (1), LKP (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 15 (0 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Bio-Rad: 8 (https://510kreport.com/company/bio-rad)
- Bio-Rad Laboratories, Inc.: 5 (https://510kreport.com/company/bio-rad-laboratories)
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)
- Immuno Concepts, Inc.: 1 (https://510kreport.com/company/immuno-concepts)

## Its most-cited devices
- K954723: Enzyme Immunoassay Ana Screening Test Kit (1995), cited by 11
- K951798: Enzyme Immunoassay Anti-Sci-70 Antibody Test Kit (1995), cited by 1
- K000489: Enzyme Immunoassay Anti-Centromere Antibody Test (2000), cited by 1
- K951850: Enzyme Immunoassay Anti-JO-1 Antibody Test Kit (1995), cited by 1
- K932419: Anti-SS-B/LA Antibody Test (1993), cited by 1

## Recent decisions
- K001900: Enzyme Immunoassay Anti-Ssdna Antibody Test (Sep 11, 2000)
- K000489: Enzyme Immunoassay Anti-Centromere Antibody Test (Apr 5, 2000)
- K980337: Diamedix Immunosimplicity Ana (IS-Ana) Screen Test System (May 12, 1998)
- K960091: Enzyme Immunoassay Anti-Double Stranded Dna (Dsdna) Test Kit (Mar 20, 1996)
- K954723: Enzyme Immunoassay Ana Screening Test Kit (Dec 15, 1995)
- K954700: Enzyme Immunoassay Lupus Screen Test Kit (Dec 15, 1995)
- K952253: Enzyme Immunoassay Ena Plus Screening Test Kit (Aug 24, 1995)
- K951850: Enzyme Immunoassay Anti-JO-1 Antibody Test Kit (Jul 18, 1995)

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