Cleared Traditional

GEN-PROBE APTIMA COMBO 2 ASSAY

K022874 · Gen-Probe, Inc. · Microbiology
Sep 2002
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K022874 is an FDA 510(k) clearance for the GEN-PROBE APTIMA COMBO 2 ASSAY, a System, Transport, Aerobic (Class I — General Controls, product code JTW), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on September 17, 2002, 53 days after receiving the submission on July 26, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K022874 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2002
Decision Date September 17, 2002
Days to Decision 53 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JTW — System, Transport, Aerobic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

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