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FDA 510(k)

Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream

K-Number: K183097 · 2019-01-10

ApplicantWeihai Kangzhou Biotechnology Engineering Co., Ltd.
Decision Date2019-01-10
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream is a medical device manufactured by Weihai Kangzhou Biotechnology Engineering Co., Ltd.. It received FDA 510(k) clearance on 2019-01-10 under approval number K183097. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream?

Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream is a medical device that received FDA 510(k) clearance on 2019-01-10. It is manufactured by Weihai Kangzhou Biotechnology Engineering Co., Ltd.. The 510(k) number is K183097.

When was Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream approved by the FDA?

Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream received FDA 510(k) clearance on 2019-01-10, under approval number K183097.

What company makes Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream?

Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream is manufactured by Weihai Kangzhou Biotechnology Engineering Co., Ltd..

What is the FDA product code for Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream?

The FDA product code for Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream is LCX.

Related Devices (Code: LCX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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