510(k) K140354

ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG by Abbott Molecular, Inc. — Product Code LSL

K140354 is an FDA 510(k) premarket notification submitted by Abbott Molecular, Inc. for the device "ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG". The FDA issued a decision of Substantially Equivalent on May 9, 2014. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Abbott Molecular, Inc. has at least 10 other 510(k) clearances on record.