510(k) K941146

DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM by Dupont Medical Products — Product Code JLW

K941146 is an FDA 510(k) premarket notification submitted by Dupont Medical Products for the device "DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 3, 1994. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Dupont Medical Products has at least 10 other 510(k) clearances on record.