510(k) K875029

ABBOTT BREATH ACETONE ANALYZER by Abbott Laboratories — Product Code JIN

K875029 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT BREATH ACETONE ANALYZER". The FDA issued a decision of Substantially Equivalent on May 27, 1988. The device falls under product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1435. Abbott Laboratories has at least 10 other 510(k) clearances on record.