510(k) K881138

CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. by Baxter Healthcare Corp — Product Code JMG

K881138 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.". The FDA issued a decision of Substantially Equivalent on April 21, 1988. The device falls under product code JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin), a Class II device regulated under 21 CFR 866.5340. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.