Substantially Equivalent 510(k) Device Information
Applicant: Verax Biomedical Incorporated, Worcester, MA
510(k) number: BK070044
Product: Platelet PGD Test System
Date: 9/17/2007
Summary (PDF - 280 KB)
FDA Clears for Marketing First Rapid Test to Screen for Bacterial Contamination in Blood Platelets - 9/18/2007