Cleared Traditional

K810546 - CEFOTAXIME 30 MCG. SENSITIVITY DISCS.

K810546 is the FDA 510(k) clearance for CEFOTAXIME 30 MCG. SENSITIVITY DISCS. by Difco Laboratories, Inc.. It is a Class 2 Immunology device (product code JTN) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K810546 · Difco Laboratories, Inc. · Immunology device
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Mar 1981
Decision
32d
Days
Class 2
Risk

K810546 is an FDA 510(k) clearance for the CEFOTAXIME 30 MCG. 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 March 31, 1981 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.1620 - the FDA immunology 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 K810546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1981
Decision Date March 31, 1981
Days to Decision 32 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 104d · This submission: 32d
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 Immunology 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 K810546.
MEZLOCILLIN 75 MCG. SENSI-DISC
K812571 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1981
MEZLOCILLIN 75 MCG. SENSITIVITY DISCS
K812525 · Difco Laboratories, Inc. · Oct 1981
PARA-PAK
K811377 · Meridian Diagnostics, Inc. · Jun 1981
CEFOTAXIME 30 MCG. SENSI-DISC.
K810564 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1981
MINOCYCLINE 30MCG. SENSI DISC
K802194 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1980
MINOCYCLINE 30 MCG. SENSITIVITY DISCS
K802178 · Difco Laboratories, Inc. · Oct 1980