510(k) K811461

EMIT-AND METHOTREXATE CONTROL by Syva Co. — Product Code LAZ

K811461 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "EMIT-AND METHOTREXATE CONTROL". The FDA issued a decision of Substantially Equivalent on June 9, 1981. The device falls under product code LAZ (N-Acetylprocainamide Control Materials), a Class I device regulated under 21 CFR 862.3280. Syva Co. has at least 10 other 510(k) clearances on record.