Cleared Traditional

K964203 - PIPERACILLIN/TAZOBACTAM 4

K964203 is an FDA 510(k) clearance for PIPERACILLIN/TAZOBACTAM 4, manufactured by Ab Biodisk. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K964203 · Ab Biodisk · Microbiology device
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Dec 1996
Decision
77d
Days
Class 2
Risk

K964203 is an FDA 510(k) clearance for the PIPERACILLIN/TAZOBACTAM 4. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Ab Biodisk (Solna, SE). The FDA issued a Cleared decision on December 18, 1996 after a review of 77 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 devices

FDA 510(k) Submission Details - K964203

510(k) Number K964203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1996
Decision Date December 18, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 102d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

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 404
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K964203.
ETEST SPARFLOXACIN
K970820 · Ab Biodisk · Apr 1997
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
K965190 · Accumed Intl., Inc. · Mar 1997
STREPTOCOCCUS MIC PANEL
K963641 · Dade Microscan, Inc. · Dec 1996
ETEST FOR CEFEPIME
K963107 · Ab Biodisk · Oct 1996
ETEST SUBMISSION FOR AMOXICILLIN
K960991 · Ab Biodisk · Oct 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K962867 · Sensititre Alamar · Sep 1996