510(k) K874303

STAPHYLASE TEST by Oxoid U.S.A., Inc. — Product Code LHT

K874303 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "STAPHYLASE TEST". The FDA issued a decision of Substantially Equivalent on November 6, 1987. The device falls under product code LHT (Staphylococcus Aureus Somatic Antigens), a Class I device regulated under 21 CFR 866.3700. Oxoid U.S.A., Inc. has at least 10 other 510(k) clearances on record.