510(k) K972524

DRIED GRAM-POSITIVE MIC/COMBO PANELS by Dade Intl., Inc. — Product Code JWY

K972524 is an FDA 510(k) premarket notification submitted by Dade Intl., Inc. for the device "DRIED GRAM-POSITIVE MIC/COMBO PANELS". The FDA issued a decision of Substantially Equivalent on September 8, 1997. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Dade Intl., Inc. has at least 10 other 510(k) clearances on record.