# Hemodiagnostica, LLC

- Location (FDA's records): Johns Island, SC
- FDA decisions: 1 (2006–2006): 1 510(k) clearance
- Product codes: CFR (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (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 whose devices it cites most
- Ciba Corning Diagnostics Corp.: 2 (https://510kreport.com/company/ciba-corning-diagnostics)
- Tech-Neal Scientific, Inc.: 2 (https://510kreport.com/company/tech-neal-scientific)

## Recent decisions
- K061879: Sdi CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System (Dec 15, 2006)

Source page: https://510kreport.com/company/hemodiagnostica