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 EquivalentCo-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.. Device class: 2.
Clearance details
- Applicant
- Co-Innovation Biotech Co., Ltd.
- Product code
- Code LCX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Guangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.