Cleared Traditional

K850957 - GENERAL DIAGNOSTICS TICARCILLIN 75MCG S...

K850957 is the FDA 510(k) clearance for GENERAL DIAGNOSTICS TICARCILLIN 75MCG S... by Warner-Lambert Co.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K850957 · Warner-Lambert Co. · Microbiology device
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May 1985
Decision
54d
Days
Class 2
Risk

K850957 is an FDA 510(k) clearance for the GENERAL DIAGNOSTICS TICARCILLIN 75MCG SUSCEPT-DISK. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on May 1, 1985 after a review of 54 days - a notably fast clearance cycle.

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: 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 Warner-Lambert Co. devices

Submission Details

510(k) Number K850957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1985
Decision Date May 01, 1985
Days to Decision 54 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
48d faster than avg
Panel avg: 102d · This submission: 54d
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 K850957.
GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK
K852967 · Warner-Lambert Co. · Aug 1985
CEFTAZIDIME 30 MCG SENSITVITY DISCS
K852835 · Difco Laboratories, Inc. · Aug 1985
TIMENTIN 85 MCG. SENSI-DISC
K851622 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1985
GENERAL DIAGNOSTICS AUGMENTIN 30MCG SUSCEP DISK
K851228 · Warner-Lambert Co. · Apr 1985
CEFTRIAXONE 30 MCG SENSITIVITY DISCS
K850606 · Difco Laboratories, Inc. · Apr 1985
AMDINOCILLIN 10 MCG SENSI-DISC
K850357 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1985