Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye— 510(k) K191021

Substantially Equivalent

Terragene S.A.

FDA 510(k) clearance K191021 for Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye, Substantially Equivalent on 2019-09-13. Applicant: Terragene S.A..

Clearance details

Applicant: Terragene S.A.
Product code: Code FRC
Advisory panel: General Hospital
Date received: 2019-04-17
Decision date: 2019-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alvear, AR

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