Breaking news! YHLO received FDA 510(k) clearance
Recently, YHLO iFlash 3000-C Chemiluminescence Analyzer and HCG Test Kit have received FDA 510(k) clearance. It is YHLO’s first 100% independently cleared by FDA.
FDA clearance for In Vitro Diagnostic (IVD) products is a crucial regulatory step in the United States. When the FDA clears an IVD product, it means that the product has undergone a thorough evaluation and signifies that the product is considered safe and effective for use in diagnosing specific medical conditions. This clearance ensures that the product complies with the regulatory requirements in the United States. It is also essential for gaining market access and building trust among laboratory professionals and patients.
As early as 2021, the company's iFlash 1800-A (also known as iFlash 3000-H) Chemiluminescence Analyzer had received FDA 510(k) clearance through a strategic partnership with Diazyme Laboratories Inc. The recent clearance of these two products by FDA 510(k) signifies that YHLO’s product quality has reached a high standard, laying a solid foundation for the company's long-term global strategic development.
YHLO is committed to steadfastly upholding its mission, which revolves around "Focusing on healthcare, better life with technology." The company is dedicated to offering increasingly precise and swift solutions for clinical diagnostics, contributing significantly to the high-quality advancement of the medical device industry. YHLO remains unwavering in its commitment to consistently deliver products and services of exceptional quality, all geared towards advancing human health and well-being.