# Immuno Concepts, Inc.

- Location (FDA's records): Sacramento, CA
- FDA decisions: 36 (1981–2001): 36 510(k) clearances
- Product codes: LLL (8), DHN (7), MOB (4), LSE (2), LKQ (2), GNP (2), LIN (2), MID (2), LJN (2), LLM (2), LJM (2), KTL (1)
- Predicates its devices cite: 13 (7 its own); citations of its devices by later devices: 9 (7 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
- The Binding Site, Ltd.: 3 (https://510kreport.com/company/binding-site)
- Inova Diagnostics, Inc.: 2 (https://510kreport.com/company/inova-diagnostics)
- Helix Diagnostics, Inc.: 1 (https://510kreport.com/company/helix-diagnostics)

## Firms that cite its devices most
- Mbl International Corporation: 1 (https://510kreport.com/company/mbl-international)
- Euroimmun Us, Inc.: 1 (https://510kreport.com/company/euroimmun-us)

## Its most-cited devices
- K935129: Relisa Ena Antibody Screening Test System (1994), cited by 5
- K972145: Hep-2000 Fluorescent Ana-RO Test System (1998), cited by 2
- K955603: Relsia SS-a/RO & SS/B LA Antibody Test System (1996), cited by 2

## Recent decisions
- K013432: Igg Anti-Ndna Fluorescent Test System; Model # 3040G (Nov 29, 2001)
- K013285: Relisa Mpo-Anca Test System for Antibodies to Myeloperoxidase, Model # 7096-15 (Nov 14, 2001)
- K013283: Relisa PR3-Anca Test System for Antibodies to Proteinase 3, Model # 7096-16 (Nov 14, 2001)
- K992041: Relisa Ana Screening Test System, Model 7096-11 (Jul 23, 1999)
- K983924: Hep-2000 Colorzyme Ana-RO Test System, Model 4200-RO (Dec 18, 1998)
- K972145: Hep-2000 Fluorescent Ana-RO Test System (Feb 24, 1998)
- K974478: Immuno Concepts Anca Test Systems (Feb 9, 1998)
- K974463: Immuno Concepts Anca Test System (Feb 9, 1998)

Source page: https://510kreport.com/company/immuno-concepts