510(k) K891480

YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER by Yellow Springs Instrument Co., Inc. — Product Code CGA

K891480 is an FDA 510(k) premarket notification submitted by Yellow Springs Instrument Co., Inc. for the device "YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER". The FDA issued a decision of Substantially Equivalent on May 22, 1989. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Yellow Springs Instrument Co., Inc. has at least 10 other 510(k) clearances on record.