Cleared Traditional

ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST

K896493 · Gen-Probe, Inc. · Microbiology
Apr 1990
Decision
149d
Days
Class 1
Risk

About This 510(k) Submission

K896493 is an FDA 510(k) clearance for the ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST, a Dna-reagents, Mycobacterium Spp. (Class I — General Controls, product code LQF), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on April 11, 1990, 149 days after receiving the submission on November 13, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3370.

Submission Details

510(k) Number K896493 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1989
Decision Date April 11, 1990
Days to Decision 149 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LQF — Dna-reagents, Mycobacterium Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3370

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