510(k) K811558

TSH-P.E.G. by Nuclear Diagnostics, Inc. — Product Code JLW

K811558 is an FDA 510(k) premarket notification submitted by Nuclear Diagnostics, Inc. for the device "TSH-P.E.G.". The FDA issued a decision of Substantially Equivalent on June 18, 1981. 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.