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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 the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2018-02-28 under 510(k) 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. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K180255.

When did CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup receive FDA 510(k) clearance?

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

Who is the listed applicant for CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup?

The FDA 510(k) record lists Hangzhou Clongene Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Hangzhou Clongene Biotech Co., Ltd. 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.

K253318Clungene RSV Antigen Rapid TestK252118CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupK242802CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteK193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test MidstreamK190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupK181790CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

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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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