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FDA 510(k)

RANDOX METABOLITE (EDDP) ASSAY

K-Number: K092258 · 2010-11-09

ApplicantRandox Laboratories, Ltd.
Decision Date2010-11-09
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RANDOX METABOLITE (EDDP) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2010-11-09 under 510(k) number K092258. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX METABOLITE (EDDP) ASSAY?

RANDOX METABOLITE (EDDP) ASSAY is a medical device that received FDA 510(k) clearance on 2010-11-09. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K092258.

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

RANDOX METABOLITE (EDDP) ASSAY received FDA 510(k) clearance on 2010-11-09, under 510(k) number K092258.

Who is the listed applicant for RANDOX METABOLITE (EDDP) ASSAY?

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

What is the FDA product code for RANDOX METABOLITE (EDDP) ASSAY?

The FDA product code for RANDOX METABOLITE (EDDP) ASSAY is DJR.

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Other records listing Randox Laboratories, Ltd. 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.

K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

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Related Devices (Code: DJR)

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.

K192433LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc.K182779ARK EDDP AssayArk Diagnostics, Inc.K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsLin-Zhi International, Inc.K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)W.H.P.M., Inc.K131232WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)Guangzhou Wondfo Biotech Co., Ltd.K092272RANDOX METHADONE ASSAYRandox Laboratories, Ltd.

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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