510(k) K833546

MODIFICATION OF EMIT AND AMIKACIN ASSAY by Syva Co. — Product Code LDN

K833546 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "MODIFICATION OF EMIT AND AMIKACIN ASSAY". The FDA issued a decision of Substantially Equivalent on December 8, 1983. The device falls under product code LDN (Enzymatic Radiochemical Assay, Amikacin), a Class II device regulated under 21 CFR 862.3035. Syva Co. has at least 10 other 510(k) clearances on record.