FDA 510(k)

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

Numéro K : K183097 · 2019-01-10

DemandeurWeihai Kangzhou Biotechnology Engineering Co., Ltd.

Date de décision2019-01-10

Code produitLCX

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Weihai Kangzhou Biotechnology Engineering Co., Ltd.. The 510(k) number is K183097.

When did Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream receive FDA 510(k) clearance?

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 510(k) number K183097.

Who is the listed applicant for Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream?

The FDA 510(k) record lists Weihai Kangzhou Biotechnology Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : LCX)

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Source officielle

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