510(k) K874375

ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL by Abbott Laboratories — Product Code LIQ

K874375 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL". The FDA issued a decision of Substantially Equivalent on December 10, 1987. The device falls under product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus), a Class I device regulated under 21 CFR 866.3405. Abbott Laboratories has at least 10 other 510(k) clearances on record.