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FDA 510(k)

RANDOX OPIATES ASSAY

K-Number: K113747 · 2012-08-24

ApplicantRandox Laboratories Limited
Decision Date2012-08-24
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RANDOX OPIATES ASSAY 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 2012-08-24 under 510(k) number K113747. 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 RANDOX OPIATES ASSAY?

RANDOX OPIATES ASSAY is a medical device that received FDA 510(k) clearance on 2012-08-24. The listed applicant is Randox Laboratories Limited. The 510(k) number is K113747.

When did RANDOX OPIATES ASSAY receive FDA 510(k) clearance?

RANDOX OPIATES ASSAY received FDA 510(k) clearance on 2012-08-24, under 510(k) number K113747.

Who is the listed applicant for RANDOX OPIATES ASSAY?

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 RANDOX OPIATES ASSAY?

The FDA product code for RANDOX OPIATES ASSAY is DJG.

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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.

K250741Evidence MultiSTAT DOA Urine MultiPlexK221550Evidence MultiSTAT DOA Urine MultiPlexK220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATK162275Randox RX Daytona Plus Alkaline Phosphatase (ALP)K161691Direct LDL Cholesterol (LDL)K152343Direct Bilirubin

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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.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI 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.

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.

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