510(k) K041165

FSH MENOPAUSE PREDICTOR TEST by ACON Laboratories, Inc. — Product Code CGJ

K041165 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "FSH MENOPAUSE PREDICTOR TEST". The FDA issued a decision of Substantially Equivalent on June 17, 2004. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.