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

FDA 510(k)

AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test

K-Number: K234006 · 2024-03-21

ApplicantAllsource Screening Solutions
Decision Date2024-03-21
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test is the device name listed in this FDA 510(k) record. The listed applicant is Allsource Screening Solutions. It received FDA 510(k) clearance on 2024-03-21 under 510(k) number K234006. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test?

AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Allsource Screening Solutions. The 510(k) number is K234006.

When did AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test receive FDA 510(k) clearance?

AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test received FDA 510(k) clearance on 2024-03-21, under 510(k) number K234006.

Who is the listed applicant for AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test?

The FDA 510(k) record lists Allsource Screening Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test?

The FDA product code for AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test is NGL.

Related Devices (Code: NGL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardHealgen Scientific,, LLCK250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd.K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd.K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup PlusGuangzhou Decheng Biotechnology Co., Ltd.K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupHealgen Scientific,, LLCK243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, 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.

↑