Cleared Traditional

K812524 - PIPERACILLIN 100 MCG. SENSITIVITY DISCS

K812524 is an FDA 510(k) clearance for PIPERACILLIN 100 MCG. SENSITIVITY DISCS, manufactured by Difco Laboratories, Inc.. The device is a Class 2 Immunology device with product code JTN cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K812524 · Difco Laboratories, Inc. · Immunology device
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Jan 1982
Decision
148d
Days
Class 2
Risk

K812524 is an FDA 510(k) clearance for the PIPERACILLIN 100 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 January 28, 1982 after a review of 148 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Difco Laboratories, Inc. devices

FDA 510(k) Submission Details - K812524

510(k) Number K812524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1981
Decision Date January 28, 1982
Days to Decision 148 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
43d slower than avg
Panel avg: 105d · This submission: 148d
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 Immunology 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 K812524.
CEFOPERAZONE 75MCG SENSIT- DISCS
K821262 · Difco Laboratories, Inc. · 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. SENSI DISC
K813441 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981
METRONIDAZOLE 80MCG. SENSI-DISC
K813387 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981
MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK
K812994 · General Diagnostics · Dec 1981