Cleared Traditional

ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE

K897078 · Gen-Probe, Inc. · Microbiology
May 1990
Decision
131d
Days
Class 1
Risk

About This 510(k) Submission

K897078 is an FDA 510(k) clearance for the ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE, 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 May 2, 1990, 131 days after receiving the submission on December 22, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3370.

Submission Details

510(k) Number K897078 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 1989
Decision Date May 02, 1990
Days to Decision 131 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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