Cleared Traditional

K950328 - AMOXICILLIN/CLAVULANIC ACID 2/1

K950328 is the FDA 510(k) clearance for AMOXICILLIN/CLAVULANIC ACID 2/1 by Ab Biodisk North America, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K950328 · Ab Biodisk North America, Inc. · Microbiology device
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Apr 1995
Decision
85d
Days
Class 2
Risk

K950328 is an FDA 510(k) clearance for the AMOXICILLIN/CLAVULANIC ACID 2/1. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Ab Biodisk North America, Inc. (S-17136 Solna, Sweden, SE). The FDA issued a Cleared decision on April 14, 1995 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Ab Biodisk North America, Inc. devices

Submission Details

510(k) Number K950328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1995
Decision Date April 14, 1995
Days to Decision 85 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 102d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 361
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K950328.
TICARCILLIN/CLAVULANIC ACID 2
K951879 · Ab Biodisk · Jul 1995
E TEST FOR OFLOXACIN
K946364 · Ab Biodisk · May 1995
DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
K950817 · Baxter Diagnostics, Inc. · Apr 1995
ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS
K945433 · Ab Biodisk · Mar 1995
SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP
K944753 · Radiometer America, Inc. · Feb 1995
LORACARBEF GRAM-NAGATIVE PANELS
K940917 · Baxter Diagnostics, Inc. · Feb 1995