Cleared Traditional

ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST

K896494 · Gen-Probe, Inc. · Microbiology
Aug 1990
Decision
283d
Days
Class 1
Risk

About This 510(k) Submission

K896494 is an FDA 510(k) clearance for the ACCUPROBE MYCOBACTERIUM AVIUM 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 August 23, 1990, 283 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 K896494 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1989
Decision Date August 23, 1990
Days to Decision 283 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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