# Nichols Institute

- Location (FDA's records): San Juan Capistrano, CA
- FDA decisions: 15 (1990–1996): 15 510(k) clearances
- Product codes: CFL (2), GGT (2), JKC (2), MSJ (1), JNL (1), JZG (1), CGR (1), JZO (1), JLW (1), CDP (1), CKG (1), JJX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (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
- Nichols Institute Diagnostics: 2 (https://510kreport.com/company/nichols-institute-diagnostics)

## Its most-cited devices
- K931311: Thyroid Peroxidase Auto Antibodies (Tpo) Immun Kit (1993), cited by 1
- K952559: Erythropoietin Immunoassay Kit (1996), cited by 1

## Recent decisions
- K952559: Erythropoietin Immunoassay Kit (May 29, 1996)
- K952505: Insulin-Like Growth Factor I (Igf-I), Immunoradiometeric Assay (Irma) (Jul 3, 1995)
- K946247: Igfbp-3; Insulin-Like Growth Factor Binding Protein-3 (Jun 23, 1995)
- K950524: Nichols Institute Diagnostics Dhea-S Chemiluminescence Immunoassay (May 15, 1995)
- K932650: Erythropoietin Immunoassay Kit (Mar 11, 1994)
- K931600: Chemiluminescence Free T3 Immunoassay (Sep 8, 1993)
- K931777: Apo a-1 Chemiluminescence Assay (Aug 16, 1993)
- K931601: Chemiluminescence Dhea-S Immunoassay (Jul 27, 1993)

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