Cleared Traditional

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

K033522 · Trek Diagnostic Systems, Inc. · Microbiology
Feb 2004
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K033522 is an FDA 510(k) clearance for the SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Trek Diagnostic Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on February 3, 2004, 88 days after receiving the submission on November 7, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K033522 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2003
Decision Date February 03, 2004
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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

Similar Devices — JWY Manual Antimicrobial Susceptibility Test Systems

All 438
MTS Aztreonam-Avibactam 0.016/4 - 256/4 ?g/mL
K252114 · Liofilchem S. R. L. · Oct 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
K252062 · Thermo Fisher Scientific · Sep 2025
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
K250575 · Thermo Fisher Scientific · Sep 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
K252014 · Thermo Fisher Scientific · Aug 2025
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 ?g/mL (SUD)
K251580 · Liofilchem S. R. L. · Aug 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
K250990 · Thermo Fisher Scientific · Jun 2025