FDA 510(k)

INSTANT-VIEW METHADONE URINE DIP STRIP TEST

K-Number: K010014 · 2001-05-29

Decision Date2001-05-29

Product CodeDJR

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

INSTANT-VIEW METHADONE URINE DIP STRIP TEST is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Scientific Designs, Inc.. It received FDA 510(k) clearance on 2001-05-29 under 510(k) number K010014. 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 INSTANT-VIEW METHADONE URINE DIP STRIP TEST?

INSTANT-VIEW METHADONE URINE DIP STRIP TEST is a medical device that received FDA 510(k) clearance on 2001-05-29. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K010014.

When did INSTANT-VIEW METHADONE URINE DIP STRIP TEST receive FDA 510(k) clearance?

INSTANT-VIEW METHADONE URINE DIP STRIP TEST received FDA 510(k) clearance on 2001-05-29, under 510(k) number K010014.

Who is the listed applicant for INSTANT-VIEW METHADONE URINE DIP STRIP TEST?

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

What is the FDA product code for INSTANT-VIEW METHADONE URINE DIP STRIP TEST?

The FDA product code for INSTANT-VIEW METHADONE URINE DIP STRIP TEST is DJR.

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Other records listing Alfa Scientific Designs, Inc. as applicant

K262299Instant-View® hCG Combo II Cassette Test K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)K173212Instant-view-PLUS immunochemical Fecal Occult Blood Test K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)K131645INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)K100051INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)

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Related Devices (Code: DJR)

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.