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FDA 510(k)

Evidence MultiSTAT DOA Urine MultiPlex

K-Number: K250741 · 2026-01-23

ApplicantRandox Laboratories Limited
Decision Date2026-01-23
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Evidence MultiSTAT DOA Urine MultiPlex is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories Limited. It received FDA 510(k) clearance on 2026-01-23 under 510(k) number K250741. 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 Evidence MultiSTAT DOA Urine MultiPlex?

Evidence MultiSTAT DOA Urine MultiPlex is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Randox Laboratories Limited. The 510(k) number is K250741.

When did Evidence MultiSTAT DOA Urine MultiPlex receive FDA 510(k) clearance?

Evidence MultiSTAT DOA Urine MultiPlex received FDA 510(k) clearance on 2026-01-23, under 510(k) number K250741.

Who is the listed applicant for Evidence MultiSTAT DOA Urine MultiPlex?

The FDA 510(k) record lists Randox Laboratories Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evidence MultiSTAT DOA Urine MultiPlex?

The FDA product code for Evidence MultiSTAT DOA Urine MultiPlex is DJG.

Other records listing Randox Laboratories Limited as applicant

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.

K221550Evidence MultiSTAT DOA Urine MultiPlexK220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATK230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K162275Randox RX Daytona Plus Alkaline Phosphatase (ALP)

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Related Devices (Code: DJG)

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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.K240124BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd.

Official Source

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

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