Cleared Traditional

COBAS 4800 CT / NG TEST

K110923 · Roche Molecular Systems, Inc. · Microbiology
Jan 2012
Decision
298d
Days
Class 1
Risk

About This 510(k) Submission

K110923 is an FDA 510(k) clearance for the COBAS 4800 CT / NG TEST, a Dna Probe, Nucleic Acid Amplification, Chlamydia (Class I — General Controls, product code MKZ), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 24, 2012, 298 days after receiving the submission on April 1, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K110923 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2011
Decision Date January 24, 2012
Days to Decision 298 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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