510(k) K953221

ABBOTT VISION HEMOGLOBIN (MODIFICATION) by Abbott Laboratories — Product Code KHG

K953221 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT VISION HEMOGLOBIN (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on September 29, 1995. 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.