Cleared Traditional

K843359 - URINE TRANSPORT KIT

K843359 is an FDA 510(k) clearance for URINE TRANSPORT KIT, manufactured by Applied Polytechnology, Inc.. The device is a Class 1 Microbiology device with product code JTW cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K843359 · Applied Polytechnology, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1984
Decision
31d
Days
Class 1
Risk

K843359 is an FDA 510(k) clearance for the URINE TRANSPORT KIT. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Applied Polytechnology, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1984 after a review of 31 days - a notably fast clearance cycle.

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: 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 Applied Polytechnology, Inc. devices

FDA 510(k) Submission Details - K843359

510(k) Number K843359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date September 27, 1984
Days to Decision 31 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 102d · This submission: 31d
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 30
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K843359.
CULTURESWAB TRANSPORT SYSTEM
K934894 · Difco Laboratories, Inc. · Feb 1994
MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE
K882580 · Precision Dynamics Corp. · Jul 1988
GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK
K843341 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984
CELL-MATICS VIRAL TRANSPORT PACK
K843173 · Difco Laboratories, Inc. · Sep 1984
PRESERV TRANSPORT & CULTURE PACK
K840968 · Preventive Diagnostics Corp. · Mar 1984
PRESERV CARY BLAIR TRANSPORT PACK
K840990 · Preventive Diagnostics Corp. · Mar 1984