Cleared Traditional

GEN-PROBE APTIMA COMBO 2 ASSAY

K032554 · Gen-Probe, Inc. · Microbiology
Dec 2003
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K032554 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 December 31, 2003, 134 days after receiving the submission on August 19, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K032554 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2003
Decision Date December 31, 2003
Days to Decision 134 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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

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