Cleared Traditional

ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST

K896492 · Gen-Probe, Inc. · Microbiology
Apr 1990
Decision
154d
Days
Class 1
Risk

About This 510(k) Submission

K896492 is an FDA 510(k) clearance for the ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE 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 16, 1990, 154 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 K896492 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1989
Decision Date April 16, 1990
Days to Decision 154 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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