Cleared Traditional

K944275 - DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.

K944275 is an FDA 510(k) clearance for DISPENS-O-DISC PIPERACILLIN 100 MCG./TA..., 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 111-day FDA review.

K944275 · Difco Laboratories, Inc. · Microbiology device
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Dec 1994
Decision
111d
Days
Class 2
Risk

K944275 is an FDA 510(k) clearance for the DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on December 19, 1994 after a review of 111 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 - K944275

510(k) Number K944275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1994
Decision Date December 19, 1994
Days to Decision 111 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 102d · This submission: 111d
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 K944275.
STREPTOMYCIN DISK (300MCG)
K961819 · Remel, L.P. · Jul 1996
CEFEPIME, 30 MCG, SENSI-DISC
K961188 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1996
REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
K955669 · Remel Co. · Feb 1996
GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS
K943407 · Becton Dickinson Microbiology Systems · Oct 1994
REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG
K935975 · Remel, Inc. · Sep 1994
PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC
K940359 · Becton Dickinson Microbiology Systems · Mar 1994