Cleared Traditional

K934894 - CULTURESWAB TRANSPORT SYSTEM

K934894 is an FDA 510(k) clearance for CULTURESWAB TRANSPORT SYSTEM, manufactured by Difco Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JTW cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K934894 · Difco Laboratories, Inc. · Microbiology device
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Feb 1994
Decision
140d
Days
Class 1
Risk

K934894 is an FDA 510(k) clearance for the CULTURESWAB TRANSPORT SYSTEM. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Difco Laboratories, Inc. devices

FDA 510(k) Submission Details - K934894

510(k) Number K934894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1993
Decision Date February 22, 1994
Days to Decision 140 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 102d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

JTW Device Classification - Class 1, General Controls

Product Code JTW System, Transport, Aerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - JTW System, Transport, Aerobic

All 28
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K934894.
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
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K843341 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984
CELL-MATICS VIRAL TRANSPORT PACK
K843173 · Difco Laboratories, Inc. · Sep 1984