Cleared Special

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

K213808 · Co-Innovation Biotech Co., Ltd. · Chemistry
Apr 2022
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K213808 is an FDA 510(k) clearance for 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, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on April 5, 2022, 120 days after receiving the submission on December 6, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K213808 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2021
Decision Date April 05, 2022
Days to Decision 120 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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