510(k) K880039

AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665 by Sigma Diagnostics, Inc. — Product Code JJX

K880039 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665". The FDA issued a decision of Substantially Equivalent on Feb 24, 1988. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.