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— 510(k) K213808

Substantially Equivalent

Co-Innovation Biotech Co., Ltd.

FDA 510(k) clearance K213808 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, Substantially Equivalent on 2022-04-05. Applicant: Co-Innovation Biotech Co., Ltd..

Clearance details

Applicant: Co-Innovation Biotech Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2021-12-06
Decision date: 2022-04-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Guangzhou, CN

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