Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Terragene Chemdye

K-Number: K200272 · 2020-06-30

ApplicantTerragene S.A.
Decision Date2020-06-30
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Terragene Chemdye is a medical device manufactured by Terragene S.A.. It received FDA 510(k) clearance on 2020-06-30 under approval number K200272. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Terragene Chemdye?

Terragene Chemdye is a medical device that received FDA 510(k) clearance on 2020-06-30. It is manufactured by Terragene S.A.. The 510(k) number is K200272.

When was Terragene Chemdye approved by the FDA?

Terragene Chemdye received FDA 510(k) clearance on 2020-06-30, under approval number K200272.

What company makes Terragene Chemdye?

Terragene Chemdye is manufactured by Terragene S.A..

What is the FDA product code for Terragene Chemdye?

The FDA product code for Terragene Chemdye is JOJ.

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 K191021Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene 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: JOJ)

K161024Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeCanadian Technical Tape, Ltd. K160485VERIFY VH2O2 Indicator TapeSTERIS Corporation K152630VERIFY STEAM Integrating IndicatorSTERIS Corporation K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. K172472Micro-MEC 1.8% Glutaraldehyde Monitor StripSTERIS Corporation K170439AN87 DosimeterAndersen 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.

↑