Cleared Traditional

ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE

K921435 · Gen-Probe, Inc. · Microbiology
Jul 1992
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K921435 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 July 23, 1992, 120 days after receiving the submission on March 25, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3370.

Submission Details

510(k) Number K921435 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1992
Decision Date July 23, 1992
Days to Decision 120 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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