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)

Immunalysis Tapentadol Urine HEIA

K-Number: K203527 · 2022-05-09

ApplicantLmmunalysis Corporation
Decision Date2022-05-09
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Immunalysis Tapentadol Urine HEIA is a medical device manufactured by Lmmunalysis Corporation. It received FDA 510(k) clearance on 2022-05-09 under approval number K203527. 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 Immunalysis Tapentadol Urine HEIA?

Immunalysis Tapentadol Urine HEIA is a medical device that received FDA 510(k) clearance on 2022-05-09. It is manufactured by Lmmunalysis Corporation. The 510(k) number is K203527.

When was Immunalysis Tapentadol Urine HEIA approved by the FDA?

Immunalysis Tapentadol Urine HEIA received FDA 510(k) clearance on 2022-05-09, under approval number K203527.

What company makes Immunalysis Tapentadol Urine HEIA?

Immunalysis Tapentadol Urine HEIA is manufactured by Lmmunalysis Corporation.

What is the FDA product code for Immunalysis Tapentadol Urine HEIA?

The FDA product code for Immunalysis Tapentadol Urine HEIA is DJG.

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.

↑