510(k) K921787

SYNELISA TPO ANTIBODIES by Elias U.S.A., Inc. — Product Code JNL

K921787 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "SYNELISA TPO ANTIBODIES". The FDA issued a decision of Substantially Equivalent on July 28, 1992. The device falls under product code JNL (Immunochemical, Thyroglobulin Autoantibody), a Class II device regulated under 21 CFR 866.5870. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.