Cleared Traditional

VIRTRAN VIRAL TRANPORTER

K851378 · Diagnon Corp. · Microbiology
Jun 1985
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K851378 is an FDA 510(k) clearance for the VIRTRAN VIRAL TRANPORTER, a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Diagnon Corp. (Laurel, US). The FDA issued a Cleared decision on June 21, 1985, 74 days after receiving the submission on April 8, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K851378 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1985
Decision Date June 21, 1985
Days to Decision 74 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LIO — Device, Specimen Collection
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

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