510(k) K791217

TSH RIA KIT by Antibodies, Inc. — Product Code JLW

K791217 is an FDA 510(k) premarket notification submitted by Antibodies, Inc. for the device "TSH RIA KIT". The FDA issued a decision of Substantially Equivalent on September 4, 1979. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Antibodies, Inc. has at least 10 other 510(k) clearances on record.