Cleared Traditional

K802303 - VIRAL TRANSPORT MED. (46-995-04)

K802303 is the FDA 510(k) clearance for VIRAL TRANSPORT MED. (46-995-04) by Flow Laboratories, Inc.. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K802303 · Flow Laboratories, Inc. · Microbiology device
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Oct 1980
Decision
38d
Days
Class 1
Risk

K802303 is an FDA 510(k) clearance for the VIRAL TRANSPORT MED. (46-995-04). Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 38 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 Flow Laboratories, Inc. devices

Submission Details

510(k) Number K802303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1980
Decision Date October 31, 1980
Days to Decision 38 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 102d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-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.

Regulatory Peers - JSM Culture Media, Non-propagating Transport

All 49
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K802303.
CHLAMYDIAL TRANSPORT MEDIUM
K834125 · Bartels Immunodiagnostic Supplies, Inc. · Feb 1984
STERILE SALINE 0.85%
K834315 · Hardy Media · Jan 1984
WATER W/TWEEN 80
K834316 · Hardy Media · Jan 1984
PARA-PAK (C&S)
K792712 · Meridian Diagnostics, Inc. · Jan 1980
TRANSPORT MEDIUM AMIES WITHOUT CHARCOAL
K791543 · Isle Media and Sterile Products, Inc. · Sep 1979
TRANSPORT MEDIUM AMIES
K791545 · Isle Media and Sterile Products, Inc. · Sep 1979