510(k) K860824

TSHK-NN RIA KIT by Cis-Us, Inc. — Product Code JLW

K860824 is an FDA 510(k) premarket notification submitted by Cis-Us, Inc. for the device "TSHK-NN RIA KIT". The FDA issued a decision of Substantially Equivalent on April 28, 1986. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Cis-Us, Inc. has at least 8 other 510(k) clearances on record.