Cleared Traditional

K833415 - TICARCILLIN 75MCG. SENSITIVITY DISCS

K833415 is an FDA 510(k) clearance for TICARCILLIN 75MCG. SENSITIVITY DISCS, manufactured by Difco Laboratories, Inc.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K833415 · Difco Laboratories, Inc. · Microbiology device
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Jan 1984
Decision
100d
Days
Class 2
Risk

K833415 is an FDA 510(k) clearance for the TICARCILLIN 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

FDA 510(k) Submission Details - K833415

510(k) Number K833415 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.

JTN Device Classification - Class 2, Special Controls

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 323
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K833415.
CEFONICID 30 MCG SENSI-DISC
K842252 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1984
GENERAL DIAG. CEFONICID 30MCG ANTIMIC
K842307 · General Diagnostics · Jul 1984
AZLOCILLIN 75MCG. SENSITIVITY DISCS
K833414 · 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
DEFAZOLIN 30MCG. SENSITIVITY DISCS
K832910 · Difco Laboratories, Inc. · Nov 1983