510(k) K864966

ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE by Diagnostics Biochem Canada, Inc. — Product Code CGF

K864966 is an FDA 510(k) premarket notification submitted by Diagnostics Biochem Canada, Inc. for the device "ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE". The FDA issued a decision of Substantially Equivalent on January 9, 1987. The device falls under product code CGF (Radioimmunoassay, Estrone), a Class I device regulated under 21 CFR 862.1280. Diagnostics Biochem Canada, Inc. has at least 5 other 510(k) clearances on record.