510(k) K020610

LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 by Bio-Rad — Product Code DIE

K020610 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529". The FDA issued a decision of Substantially Equivalent on April 22, 2002. The device falls under product code DIE (Heavy Metals Control Materials), a Class I device regulated under 21 CFR 862.3280. Bio-Rad has at least 10 other 510(k) clearances on record.