510(k) K904329

CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY by Baxter Healthcare Corp — Product Code MCB

K904329 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on March 12, 1991. The device falls under product code MCB (Antigen, C. Difficile), a Class I device regulated under 21 CFR 866.2660. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.