510(k) K962451

HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) by Hycor Biomedical, Inc. — Product Code JNL

K962451 is an FDA 510(k) premarket notification submitted by Hycor Biomedical, Inc. for the device "HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)". The FDA issued a decision of Substantially Equivalent on November 25, 1996. The device falls under product code JNL (Immunochemical, Thyroglobulin Autoantibody), a Class II device regulated under 21 CFR 866.5870. Hycor Biomedical, Inc. has at least 10 other 510(k) clearances on record.