510(k) K092704

ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 by Abbott Molecular, Inc. — Product Code LSK

K092704 is an FDA 510(k) premarket notification submitted by Abbott Molecular, Inc. for the device "ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03". The FDA issued a decision of Substantially Equivalent on May 28, 2010. The device falls under product code LSK (Dna-Reagents, Chlamydia), a Class I device regulated under 21 CFR 866.3120. Abbott Molecular, Inc. has at least 10 other 510(k) clearances on record.