Terragene® Bionova® BT20 Biological Indicator— 510(k) K251122

Substantially Equivalent

Terragene

FDA 510(k) clearance K251122 for Terragene® Bionova® BT20 Biological Indicator, Substantially Equivalent on 2025-08-04. Applicant: Terragene.

Clearance details

Applicant: Terragene
Product code: 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

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