510(k) K020625

SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 by Helena Laboratories — Product Code CIN

K020625 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346". The FDA issued a decision of Substantially Equivalent on May 6, 2002. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Helena Laboratories has at least 10 other 510(k) clearances on record.