Cleared Traditional

K953422 - FOX FASTIDIOUS TEST PANELS
(FDA 510(k) Clearance)

K953422 · Micro-Media Systems, Inc. · Microbiology
Oct 1995
Decision
92d
Days
Class 2
Risk

K953422 is an FDA 510(k) clearance for the FOX FASTIDIOUS TEST PANELS, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Micro-Media Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on October 7, 1995, 92 days after receiving the submission on July 7, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K953422 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1995
Decision Date October 07, 1995
Days to Decision 92 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