K252306

Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100)

510(k) number: K252306
Device name: Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100)
Applicant: Steritec Products CO · US
Product code: QVB — Biological Sterilization Indicator With Indirect Gro
Decision date: 2026-04-22
Date received: 2025-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K252306.pdf

Official FDA record: K252306

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.