Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator— 510(k) K163646

Substantially Equivalent

Terragene S.A.

FDA 510(k) clearance K163646 for Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator, Substantially Equivalent on 2017-11-02. Applicant: Terragene S.A..

Clearance details

Applicant: Terragene S.A.
Product code: Code FRC
Advisory panel: General Hospital
Date received: 2016-12-23
Decision date: 2017-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosario, AR

Download summary PDF View on FDA.gov ↗

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