DeviceClearance

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) K252306

Substantially Equivalent

Steritec Products

FDA 510(k) clearance K252306 for 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), Substantially Equivalent on 2026-04-22. Applicant: Steritec Products. Device class: 2.

Clearance details

Applicant
Steritec Products
Product code
Code QVB
Device class
Class 2
Regulation
21 CFR 880.2806
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Engelwood, CO, US
Download summary PDFView on FDA.gov ↗

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