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FDA 510(k)

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

K-Number: K180255 · 2018-02-28

ApplicantHangzhou Clongene Biotech Co., Ltd.
Decision Date2018-02-28
Product CodePTH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup is a medical device manufactured by Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2018-02-28 under approval number K180255. The device is classified under product code PTH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup?

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup is a medical device that received FDA 510(k) clearance on 2018-02-28. It is manufactured by Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K180255.

When was CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup approved by the FDA?

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup received FDA 510(k) clearance on 2018-02-28, under approval number K180255.

What company makes CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup?

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup is manufactured by Hangzhou Clongene Biotech Co., Ltd..

What is the FDA product code for CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup?

The FDA product code for CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup is PTH.

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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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