# Sangui Biotech, Inc.

- Location (FDA's records): Santa Ana, CA
- FDA decisions: 5 (1997–2000): 5 510(k) clearances
- Product codes: CKG (1), CEW (1), GGT (1), JKR (1), NAO (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)

## Its most-cited devices
- K992799: Sangui Biotech, Inc. Epo (Erythropoietin) Elisa Kit (2000), cited by 1

## Recent decisions
- K001943: Chronalco I.D.CDT (Carbohydrate Deficient Transferrin) Assay (Aug 23, 2000)
- K992799: Sangui Biotech, Inc. Epo (Erythropoietin) Elisa Kit (Jun 7, 2000)
- K982491: Sangui Biotech, Inc. Calcitonin Elisa Kit (Sep 3, 1998)
- K982608: Sangui Biotech, Inc. Acth (Adrenocorticotropic Hormone) Elisa Kit (Aug 19, 1998)
- K974306: Sangui Biotech, Inc. Intact-PTH (Parathyroid Hormone) Elisa (Dec 23, 1997)

Source page: https://510kreport.com/company/sangui-biotech