510(k) K781957

ANALYTICAL TEST PACK, PRIMIDONE by E.I. Dupont DE Nemours & Co., Inc. — Product Code DJD

K781957 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ANALYTICAL TEST PACK, PRIMIDONE". The FDA issued a decision of Substantially Equivalent on January 10, 1979. The device falls under product code DJD (Enzyme Immunoassay, Primidone), a Class II device regulated under 21 CFR 862.3680. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.