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FDA 510(k)

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye

K-Number: K191021 · 2019-09-13

ApplicantTerragene S.A.
Decision Date2019-09-13
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye is a medical device manufactured by Terragene S.A.. It received FDA 510(k) clearance on 2019-09-13 under approval number K191021. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye?

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Terragene S.A.. The 510(k) number is K191021.

When was Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye approved by the FDA?

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye received FDA 510(k) clearance on 2019-09-13, under approval number K191021.

What company makes Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye?

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye is manufactured by Terragene S.A..

What is the FDA product code for Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye?

The FDA product code for Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye is FRC.

Other Devices by Terragene S.A.

K163646Terragene 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 K200272Terragene Chemdye K221641Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) K242453Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) K231383Terragene® 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) DEN220042Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)

View all 8 devices →

Related Devices (Code: FRC)

K1605463M Attest Rapid Readout Biological Indicator3M Company K151482BCR-30-min BI™ and RBIP-ST30™ Readout AccessoryBcr Diagnostics, Inc. K172474Celerity 20 HP Biological IndicatorSTERIS Corporation K172432SporView Rapid Read Biological IndicatorCrosstex/Spsmedical, A Division of Cantel Medical K163646Terragene 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 IncubatorTerragene S.A. K170427Anprolene SteriTestAndersen Sterilizers, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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