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FDA 510(k)

INSTANT-VIEW MARIJUANA URINE CASSETTE TEST

K-Number: K994405 · 2000-06-02

ApplicantAlfa Scientific Designs, Inc.
Decision Date2000-06-02
Product CodeDKE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INSTANT-VIEW MARIJUANA URINE CASSETTE 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 2000-06-02 under 510(k) number K994405. The device is classified under product code DKE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTANT-VIEW MARIJUANA URINE CASSETTE TEST?

INSTANT-VIEW MARIJUANA URINE CASSETTE TEST is a medical device that received FDA 510(k) clearance on 2000-06-02. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K994405.

When did INSTANT-VIEW MARIJUANA URINE CASSETTE TEST receive FDA 510(k) clearance?

INSTANT-VIEW MARIJUANA URINE CASSETTE TEST received FDA 510(k) clearance on 2000-06-02, under 510(k) number K994405.

Who is the listed applicant for INSTANT-VIEW MARIJUANA URINE CASSETTE 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 MARIJUANA URINE CASSETTE TEST?

The FDA product code for INSTANT-VIEW MARIJUANA URINE CASSETTE TEST is DKE.

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Other records listing Alfa Scientific Designs, Inc. 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.

K262299Instant-View® hCG Combo II Cassette TestK173303INSTANT-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 TestK152122Instant-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: DKE)

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.

K003687VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COCMedtox Diagnostics, Inc.K992068STATUS STIK, ACCUSIGN STIKPrinceton BioMeditech Corp.K991751STATUS CUP ACCUSIGN CUPPrinceton BioMeditech Corp.K991078ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8Princeton BioMeditech Corp.K983147ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/PPrinceton BioMeditech Corp.K982211PROFILE-II MODEL 600582Medtox Diagnostics, 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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