Cleared Traditional

TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS

K032194 · Gen-Probe, Inc. · Microbiology
Dec 2003
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K032194 is an FDA 510(k) clearance for the TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS, 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 24, 2003, 159 days after receiving the submission on July 18, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K032194 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2003
Decision Date December 24, 2003
Days to Decision 159 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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