Cleared Traditional

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL

K180886 · Liofilchem S. R. L. · Microbiology
May 2018
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K180886 is an FDA 510(k) clearance for the Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Liofilchem S. R. L. (Roseto Degli Abruzzi, IT). The FDA issued a Cleared decision on May 18, 2018, 44 days after receiving the submission on April 4, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K180886 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2018
Decision Date May 18, 2018
Days to Decision 44 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