510(k) K862202

VISION(TM) HEMOGLOBIN by Abbott Laboratories — Product Code KHG

K862202 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "VISION(TM) HEMOGLOBIN". The FDA issued a decision of Substantially Equivalent on August 18, 1986. The device falls under product code KHG (Whole Blood Hemoglobin Determination), a Class II device regulated under 21 CFR 864.7500. Abbott Laboratories has at least 10 other 510(k) clearances on record.