Cleared Traditional

K833414 - AZLOCILLIN 75MCG. SENSITIVITY DISCS

K833414 is the FDA 510(k) clearance for AZLOCILLIN 75MCG. SENSITIVITY DISCS by Difco Laboratories, Inc.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K833414 · Difco Laboratories, Inc. · Microbiology device
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Jan 1984
Decision
100d
Days
Class 2
Risk

K833414 is an FDA 510(k) clearance for the AZLOCILLIN 75MCG. SENSITIVITY DISCS. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1984 after a review of 100 days - within the typical 510(k) review window.

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: 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

Submission Details

510(k) Number K833414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1983
Decision Date January 11, 1984
Days to Decision 100 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
2d faster than avg
Panel avg: 102d · This submission: 100d
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 K833414.
CEFONICID 30 MCG SENSITIVITY DISCS
K842292 · Difco Laboratories, Inc. · Jul 1984
CEFONICID 30 MCG SENSI-DISC
K842252 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1984
GENERAL DIAG. CEFONICID 30MCG ANTIMIC
K842307 · General Diagnostics · Jul 1984
TICARCILLIN 75MCG. SENSITIVITY DISCS
K833415 · Difco Laboratories, Inc. · Jan 1984
CEFTIZOXIME 30 MCG SENSITIVITY DISCS
K833416 · Difco Laboratories, Inc. · Jan 1984
CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK
K833709 · General Diagnostics · Dec 1983