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#Industry News
YHLO Receives FDA 510(K) Clearance for iFlash 1800 Chemiluminescence Immunoassay Analyzer and iFlash Total βhCG Assay
This FDA clearance marks an important milestone for YHLO in our commitment to improve the chemiluminescence immunoassay technologies and bring reliable IVD products all over the world. With the mission of “Focus on healthcare, better life with techno
YHLO Biotech announced today that the iFlash 1800 Chemiluminescence Immunoassay Analyzer and iFlash Total βhCG Assay have received a 510(k) clearance from the U.S. Food and Drug Administration through a local partner. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent as predicate device. Receiving the 510(K) expands YHLO’s reach of iFlash 1800, as it has been installed in nearly 100 counties globally.