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FDA 510(k)

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test

K-Number: K153741 · 2016-03-18

ApplicantHangzhou Clongene Biotech Co., Ltd.
Decision Date2016-03-18
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test is a medical device manufactured by Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2016-03-18 under approval number K153741. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test?

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K153741.

When was CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test approved by the FDA?

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test received FDA 510(k) clearance on 2016-03-18, under approval number K153741.

What company makes CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test?

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test is manufactured by Hangzhou Clongene Biotech Co., Ltd..

What is the FDA product code for CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test?

The FDA product code for CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test is LDJ.

Other Devices by Hangzhou Clongene Biotech Co., Ltd.

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Related Devices (Code: LDJ)

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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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