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)

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

K-Number: K222955 · 2023-02-06

ApplicantXenta Biomedical Science Co., Ltd.
Decision Date2023-02-06
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is a medical device manufactured by Xenta Biomedical Science Co., Ltd.. It received FDA 510(k) clearance on 2023-02-06 under approval number K222955. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is a medical device that received FDA 510(k) clearance on 2023-02-06. It is manufactured by Xenta Biomedical Science Co., Ltd.. The 510(k) number is K222955.

When was Xenta Drug Screen Cup, Xenta Drug Screen Dipcard approved by the FDA?

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard received FDA 510(k) clearance on 2023-02-06, under approval number K222955.

What company makes Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is manufactured by Xenta Biomedical Science Co., Ltd..

What is the FDA product code for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

The FDA product code for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is DJG.

Other Devices by Xenta Biomedical Science Co., Ltd.

K231137Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

Related Devices (Code: DJG)

K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 TestsChemtron Biotech, Inc. K173183CEDIA Heroin Metabolite (6-AM) AssayMicrogenics Corporation K172910Emit II Plus Oxycodone AssaySiemens Healthcare Diagnostics, Inc. K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsImmunalysis Corporation K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control SetMicrogenics Corporation

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.

↑