510(k) K864078

MODIFIED N.Y.C. FERMENTATION MEDIUM BASE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JTY

K864078 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "MODIFIED N.Y.C. FERMENTATION MEDIUM BASE". The FDA issued a decision of Substantially Equivalent on October 31, 1986. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.