K251122

Substantially Equivalent

Terragene® Bionova® BT20 Biological Indicator

Applicant: Terragene
Product code: FRC
Advisory panel: General Hospital
Date received: 2025-04-11
Decision date: 2025-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alvear, AR

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.