510(k) K870945

RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 by Oxoid U.S.A., Inc. — Product Code JTL

K870945 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122". The FDA issued a decision of Substantially Equivalent on June 10, 1987. The device falls under product code JTL (Plasma, Coagulase, Human, Horse And Rabbit), a Class I device regulated under 21 CFR 866.2160. Oxoid U.S.A., Inc. has at least 10 other 510(k) clearances on record.