# Nichols Institute Diagnostics

- Location (FDA's records): San Juan Capistrano, CA
- FDA decisions: 68 (1977–2005): 68 510(k) clearances
- Product codes: CEW (13), CEP (4), CFL (4), JLW (3), CGJ (3), JKR (3), CGR (3), CKG (3), MSW (2), CIB (2), CEC (2), CJM (2)
- Predicates its devices cite: 12 (4 its own); citations of its devices by later devices: 12 (4 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Diagnostic Products Corp.: 3 (https://510kreport.com/company/diagnostic-products)
- Nichols Institute: 2 (https://510kreport.com/company/nichols-institute)
- R&D Systems, Inc.: 1 (https://510kreport.com/company/r-d-systems)
- Orion Diagnostica, Div. Orion Corp.: 1 (https://510kreport.com/company/orion-diagnostica-div-orion)
- Ciba Corning Diagnostics Corp.: 1 (https://510kreport.com/company/ciba-corning-diagnostics)

## Firms that cite its devices most
- Fisher Diagnostics: 2 (https://510kreport.com/company/fisher-diagnostics)
- Bayer Diagnostics Corp.: 1 (https://510kreport.com/company/bayer-diagnostics)
- Little Nell Labs, Inc.: 1 (https://510kreport.com/company/little-nell-labs)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)
- Brahms Diagnostica, LLC: 1 (https://510kreport.com/company/brahms-diagnostica)

## Its most-cited devices
- K954418: Intact Parathyroid Hormone (PTH) Immunoassay (Modification) (1995), cited by 2
- K013992: Nichols Advantage Chemiluminescence Bio-Intact Parathyroid Hormone (1-84) Immunoassay (2001), cited by 2
- K962598: Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Kit (1996), cited by 1
- K994140: Nichols Chemiluminescence Thyroglobulin, Model 60-4240 (2000), cited by 1
- K972070: Nichols Advantage Chemiluminescence Tri-Level Specialty Controls (1997), cited by 1
- K964635: Nichols Advantage Chemiluminescence Calcitonin Kit (1997), cited by 1

## Recent decisions
- K050784: Nichols Advantage Aldosterone Assay (Jun 1, 2005)
- K042676: Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) Assay (Dec 17, 2004)
- K042689: Nichols Advantage Cortisol (Dec 9, 2004)
- K040813: Nichols Advantage Chemiluminescence Intact Parathyroid Hormone, Model 62-7022 (Jun 8, 2004)
- K033727: Nichols Advantage Bio-Intact PTH (1-84) Immunoassay (Apr 22, 2004)
- K033302: Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040 (Jan 26, 2004)
- K032188: Nichols Advantage Aldosterone Assay (Jul 31, 2003)
- K022356: Nichols Advantage Chemiluminescence Helicobactor Pylori Igg Antibodies Immunoassay (Oct 25, 2002)

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