510(k) K052366

ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA by Ab Biodisk — Product Code JWY

K052366 is an FDA 510(k) premarket notification submitted by Ab Biodisk for the device "ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA". The FDA issued a decision of Substantially Equivalent on October 13, 2005. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Ab Biodisk has at least 10 other 510(k) clearances on record.