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FDA 510(k)

RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020

K-Number: K023252 · 2002-11-22

ApplicantIcn Biomedicals, Inc.
Decision Date2002-11-22
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 is the device name listed in this FDA 510(k) record. The listed applicant is Icn Biomedicals, Inc.. It received FDA 510(k) clearance on 2002-11-22 under 510(k) number K023252. 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 RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020?

RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 is a medical device that received FDA 510(k) clearance on 2002-11-22. The listed applicant is Icn Biomedicals, Inc.. The 510(k) number is K023252.

When did RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 receive FDA 510(k) clearance?

RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 received FDA 510(k) clearance on 2002-11-22, under 510(k) number K023252.

Who is the listed applicant for RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020?

The FDA 510(k) record lists Icn Biomedicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020?

The FDA product code for RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 is DJR.

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Other records listing Icn Biomedicals, Inc. as applicant

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K030211RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016K926106IMMUCHEM PHE-MW EAK922944IMMUCHEM LH-MW ELISAK922376ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KITK922715IMMUCHEM PRL-MW ELISAK920442IMMUCHEM TSH-MW ELISA

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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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