Cleared Traditional

GEN-PROBE APTIMA COMBO 2 ASSAY

K003395 · Gen-Probe, Inc. · Microbiology
May 2001
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K003395 is an FDA 510(k) clearance for the GEN-PROBE APTIMA COMBO 2 ASSAY, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on May 21, 2001, 201 days after receiving the submission on November 1, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K003395 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2000
Decision Date May 21, 2001
Days to Decision 201 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LSL — Dna-reagents, Neisseria
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3390

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