510(k) K060768

PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS by Abbott Diabetes Care, Inc. — Product Code JIN

K060768 is an FDA 510(k) premarket notification submitted by Abbott Diabetes Care, Inc. for the device "PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS". The FDA issued a decision of Substantially Equivalent on April 21, 2006. The device falls under product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1435. Abbott Diabetes Care, Inc. has at least 10 other 510(k) clearances on record.