K221641

Substantially Equivalent

Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)

Applicant: Terragene S.A.
Product code: FRC
Advisory panel: General Hospital
Date received: 2022-06-06
Decision date: 2023-02-28
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.