# Iso-Tex Diagnostics

- Location (FDA's records): Walker, MI
- FDA decisions: 3 (1979–1985): 3 510(k) clearances
- Product codes: CEW (1), MSJ (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- K851389: Apo B Ria Kit (Jul 10, 1985)
- K840105: Apo a-I Ria Kit-Human Plasma Apolip- (Jan 10, 1984)
- K782081: Ria System, Parathyroid Hormone (Mar 21, 1979)

Source page: https://510kreport.com/company/iso-tex-diagnostics