Cleared Traditional

VIRTRAN VIRAL TRANSPORTER (MODIFIED) (K860967) - FDA 510(k) Clearance

Class I Microbiology device.

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

K860967 is an FDA 510(k) clearance for the VIRTRAN VIRAL TRANSPORTER (MODIFIED). Classified as Culture Media, Propagating Transport (product code JSN), Class I - General Controls.

Submitted by Diagnon Corp. (Laurel, US). The FDA issued a Cleared decision on April 4, 1986 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnon Corp. devices

Submission Details

510(k) Number K860967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1986
Decision Date April 04, 1986
Days to Decision 25 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 102d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSN Culture Media, Propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.