510(k) K171103

Lumipulse G TSH-III Immunoreaction Cartridges by Fujirebio Diagnostics,Inc. — Product Code JLW

K171103 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "Lumipulse G TSH-III Immunoreaction Cartridges". The FDA issued a decision of Substantially Equivalent on July 28, 2017. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.