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FDA 510(k)

Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

K-Number: K152122 · 2016-06-24

ApplicantAlfa Scientific Designs, Inc.
Decision Date2016-06-24
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) is a medical device manufactured by Alfa Scientific Designs, Inc.. It received FDA 510(k) clearance on 2016-06-24 under approval number K152122. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)?

Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Alfa Scientific Designs, Inc.. The 510(k) number is K152122.

When was Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) approved by the FDA?

Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) received FDA 510(k) clearance on 2016-06-24, under approval number K152122.

What company makes Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)?

Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) is manufactured by Alfa Scientific Designs, Inc..

What is the FDA product code for Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)?

The FDA product code for Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) is DKZ.

Related Clinical Trials

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Related PubMed Literature

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Other Devices by Alfa Scientific Designs, Inc.

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

Related Devices (Code: DKZ)

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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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