510(k) K822809

AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC by General Diagnostics — Product Code JTN

K822809 is an FDA 510(k) premarket notification submitted by General Diagnostics for the device "AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC". The FDA issued a decision of Substantially Equivalent on November 22, 1982. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. General Diagnostics has at least 10 other 510(k) clearances on record.