Cleared Traditional

TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY

K060652 · Gen-Probe, Inc. · Microbiology
Aug 2006
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K060652 is an FDA 510(k) clearance for the TIGRIS DTS 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 August 17, 2006, 157 days after receiving the submission on March 13, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K060652 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2006
Decision Date August 17, 2006
Days to Decision 157 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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