510(k) K883394

GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS by Baxter Healthcare Corp — Product Code JWY

K883394 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS". The FDA issued a decision of Substantially Equivalent on Sep 7, 1988. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Baxter Healthcare Corp has 507 other 510(k) clearances on record.