510(k) K823370

ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY by Syva Co. — Product Code KJI

K823370 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code KJI (Radioimmunoassay, Kanamycin), a Class II device regulated under 21 CFR 862.3520. Syva Co. has at least 10 other 510(k) clearances on record.