510(k) K812892

S/P SERUM DROPPER PIPETS by American Dade — Product Code KSS

K812892 is an FDA 510(k) premarket notification submitted by American Dade for the device "S/P SERUM DROPPER PIPETS". The FDA issued a decision of Substantially Equivalent on October 27, 1981. The device falls under product code KSS (Supplies, Blood-Bank), a Class I device regulated under 21 CFR 864.9050. American Dade has at least 10 other 510(k) clearances on record.