510(k) K891691

LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II by Bio-Rad — Product Code DIE

K891691 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II". The FDA issued a decision of Substantially Equivalent on December 19, 1989. 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.