510(k) K905829

DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS by Kamiya Biomedical Co. — Product Code CEL

K905829 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS". The FDA issued a decision of Substantially Equivalent on January 30, 1991. The device falls under product code CEL (Ammonium Molybdate And Ammonium Vanadate, Phospholipids), a Class I device regulated under 21 CFR 862.1575. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.