510(k) K812994

MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK by General Diagnostics — Product Code JTN

K812994 is an FDA 510(k) premarket notification submitted by General Diagnostics for the device "MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK". The FDA issued a decision of Substantially Equivalent on December 17, 1981. 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.