510(k) K830364

NEISSERIA IDENTIFICATION DISCS by Oxoid U.S.A., Inc. — Product Code JSX

K830364 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "NEISSERIA IDENTIFICATION DISCS". The FDA issued a decision of Substantially Equivalent on Mar 8, 1983. The device falls under product code JSX (Kit, Identification, Neisseria Gonorrhoeae), a Class I device regulated under 21 CFR 866.2660. Oxoid U.S.A., Inc. has 92 other 510(k) clearances on record.