Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)— 510(k) K231383

Substantially Equivalent

Terragene S.A.

FDA 510(k) clearance K231383 for Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40), Substantially Equivalent on 2024-09-18. Applicant: Terragene S.A..

Clearance details

Applicant: Terragene S.A.
Product code: Code FRC
Advisory panel: General Hospital
Date received: 2023-05-12
Decision date: 2024-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alvear, AR

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