510(k) K882534

ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL by Abbott Laboratories — Product Code LIR

K882534 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL". The FDA issued a decision of Substantially Equivalent on July 12, 1988. The device falls under product code LIR (Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae), a Class II device regulated under 21 CFR 866.3390. Abbott Laboratories has at least 10 other 510(k) clearances on record.