510(k) K150955

Elecsys Progesterone III Cal Check 5 by Roche Diagnostics — Product Code JJX

K150955 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Progesterone III Cal Check 5". The FDA issued a decision of Substantially Equivalent on May 1, 2015. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Roche Diagnostics has at least 10 other 510(k) clearances on record.