Cleared Traditional

ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT

K080739 · Abbott Molecular, Inc. · Microbiology
Jul 2008
Decision
115d
Days
Class 1
Risk

About This 510(k) Submission

K080739 is an FDA 510(k) clearance for the ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT, a Dna Probe, Nucleic Acid Amplification, Chlamydia (Class I — General Controls, product code MKZ), submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on July 10, 2008, 115 days after receiving the submission on March 17, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K080739 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2008
Decision Date July 10, 2008
Days to Decision 115 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MKZ — Dna Probe, Nucleic Acid Amplification, Chlamydia
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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