Cleared Traditional

K870347 - AZTREONAM 30 MCG SENSITIVITY DISKS

K870347 is the FDA 510(k) clearance for AZTREONAM 30 MCG SENSITIVITY DISKS by Difco Laboratories, Inc.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K870347 · Difco Laboratories, Inc. · Microbiology device
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Mar 1987
Decision
36d
Days
Class 2
Risk

K870347 is an FDA 510(k) clearance for the AZTREONAM 30 MCG SENSITIVITY DISKS. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on March 5, 1987 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - 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 Difco Laboratories, Inc. devices

Submission Details

510(k) Number K870347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date March 05, 1987
Days to Decision 36 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
66d faster than avg
Panel avg: 102d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTN Susceptibility Test Discs, Antimicrobial

All 282
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K870347.
NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK
K864848 · Organon Teknika Corp. · Mar 1987
NORFLOXACIN 10 MCG SENSITIVITY DISKS
K870348 · Difco Laboratories, Inc. · Mar 1987
AZTREONAM 30 MCG SUSCEPTIBILITY DISK
K870870 · Organon Teknika Corp. · Mar 1987
AZTREONAM 30 MCG. SENSI-DISC
K865034 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK
K860895 · Organon Teknika Corp. · Apr 1986
OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS
K860153 · Oxoid U.S.A., Inc. · Mar 1986