510(k) K952607

AURAFLEX TPO-AB by Organon Teknika Corp. — Product Code JNL

K952607 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "AURAFLEX TPO-AB". The FDA issued a decision of Substantially Equivalent on August 25, 1995. The device falls under product code JNL (Immunochemical, Thyroglobulin Autoantibody), a Class II device regulated under 21 CFR 866.5870. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.