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Breaking news! YHLO received FDA 510(k) clearance

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.

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.

Details

  • M7QR+56R, Bao Long Er Lu, Long Gang Qu, Shen Zhen Shi, Guang Dong Sheng, China, 518118
  • Shenzhen Yhlo Biotech Co., Ltd.