Cleared Traditional

ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST

K904463 · Gen-Probe, Inc. · Microbiology
Nov 1990
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K904463 is an FDA 510(k) clearance for the ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM 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 November 13, 1990, 43 days after receiving the submission on October 1, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3370.

Submission Details

510(k) Number K904463 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1990
Decision Date November 13, 1990
Days to Decision 43 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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