510(k) K965190

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE by Accumed Intl., Inc. — Product Code JWY

K965190 is an FDA 510(k) premarket notification submitted by Accumed Intl., Inc. for the device "SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE". The FDA issued a decision of Substantially Equivalent on Mar 19, 1997. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Accumed Intl., Inc. has 11 other 510(k) clearances on record.