510(k) K080739

ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT by Abbott Molecular, Inc. — Product Code MKZ

K080739 is an FDA 510(k) premarket notification submitted by Abbott Molecular, Inc. for the device "ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT". The FDA issued a decision of Substantially Equivalent on July 10, 2008. The device falls under product code MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia), a Class I device regulated under 21 CFR 866.3120. Abbott Molecular, Inc. has at least 10 other 510(k) clearances on record.