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FDA 510(k)

Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream

K-Number: K213808 · 2022-04-05

ApplicantCo-Innovation Biotech Co., Ltd.
Decision Date2022-04-05
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream is a medical device manufactured by Co-Innovation Biotech Co., Ltd.. It received FDA 510(k) clearance on 2022-04-05 under approval number K213808. 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 Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream?

Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream is a medical device that received FDA 510(k) clearance on 2022-04-05. It is manufactured by Co-Innovation Biotech Co., Ltd.. The 510(k) number is K213808.

When was Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream approved by the FDA?

Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream received FDA 510(k) clearance on 2022-04-05, under approval number K213808.

What company makes Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream?

Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream is manufactured by Co-Innovation Biotech Co., Ltd..

What is the FDA product code for Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream?

The FDA product code for Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream is LCX.

Other Devices by Co-Innovation Biotech Co., Ltd.

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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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