510(k) for Saliva Diagnostic Systems' Helicobacter pylori test:
This article was originally published in Clinica
Executive Summary
Saliva Diagnostic Systems of Vancouver, Washington, has received 510(k) clearance in the US for its Stat-Simple H pylori test for the rapid diagnosis of the bacterial infection responsible for various stomach ulcers and other human gastrointestinal diseases. Stat-Simple uses whole-blood samples from the patient and gives results within 15 minutes.