510(k) K964278

WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 by Clinical Controls, Inc. — Product Code JJX

K964278 is an FDA 510(k) premarket notification submitted by Clinical Controls, Inc. for the device "WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6". The FDA issued a decision of Substantially Equivalent on Nov 22, 1996. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Clinical Controls, Inc. has 17 other 510(k) clearances on record.