Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)— 510(k) K242453

Substantially Equivalent

Terragene S.A.

FDA 510(k) clearance K242453 for Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C), Substantially Equivalent on 2024-12-12. Applicant: Terragene S.A..

Clearance details

Applicant: Terragene S.A.
Product code: Code FRC
Advisory panel: General Hospital
Date received: 2024-08-19
Decision date: 2024-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alvear, AR

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