K213808

Substantially Equivalent

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

Applicant: Co-Innovation Biotech Co., Ltd.
Product 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.