510(k) K833713

SERUM THYROTROPIN ASSAY KIT, TIPSEP- by Nuclear Diagnostics, Inc. — Product Code JLW

K833713 is an FDA 510(k) premarket notification submitted by Nuclear Diagnostics, Inc. for the device "SERUM THYROTROPIN ASSAY KIT, TIPSEP-". The FDA issued a decision of Substantially Equivalent on December 29, 1983. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Nuclear Diagnostics, Inc. has at least 10 other 510(k) clearances on record.