Cleared Traditional

K821262 - CEFOPERAZONE 75MCG SENSIT- DISCS

K821262 is the FDA 510(k) clearance for CEFOPERAZONE 75MCG SENSIT- DISCS by Difco Laboratories, Inc.. It is a Class 2 Immunology device (product code JTN) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K821262 · Difco Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1982
Decision
50d
Days
Class 2
Risk

K821262 is an FDA 510(k) clearance for the CEFOPERAZONE 75MCG SENSIT- 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 June 22, 1982 after a review of 50 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 K821262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1982
Decision Date June 22, 1982
Days to Decision 50 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
54d faster than avg
Panel avg: 104d · This submission: 50d
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 K821262.
AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC
K822809 · General Diagnostics · Nov 1982
TICARCILLIN 75MCG. SENSI-DISC
K822832 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1982
CEFOPERAZONE 75MCG. ANTIMICROBIAL DISK
K821229 · General Diagnostics · Jun 1982
CEFOPERAZONE 75MCG SENSI-DISC
K821264 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1982
PIPERACILLIN 100MCG. ANTIMICROBIAL
K820019 · General Diagnostics · Jan 1982
PIPERACILLIN 100 MCG. SENSITIVITY DISCS
K812524 · Difco Laboratories, Inc. · Jan 1982