510(k) K964558

VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) by Johnson & Johnson Clinical Diagnostics, Inc. — Product Code JLW

K964558 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Clinical Diagnostics, Inc. for the device "VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)". The FDA issued a decision of Substantially Equivalent on December 16, 1996. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Johnson & Johnson Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.