Cleared Traditional

VIRTRAN VIRAL TRANSPORTER (MODIFIED)

K860967 · Diagnon Corp. · Microbiology
Apr 1986
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K860967 is an FDA 510(k) clearance for the VIRTRAN VIRAL TRANSPORTER (MODIFIED), a Culture Media, Propagating Transport (Class I — General Controls, product code JSN), submitted by Diagnon Corp. (Laurel, US). The FDA issued a Cleared decision on April 4, 1986, 25 days after receiving the submission on March 10, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K860967 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1986
Decision Date April 04, 1986
Days to Decision 25 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSN — Culture Media, Propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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