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510(k) K173307

Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL by Liofilchem S.R.L. — Product Code JWY

K173307 is an FDA 510(k) premarket notification submitted by Liofilchem S.R.L. for the device "Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL". The FDA issued a decision of Substantially Equivalent on Dec 19, 2017. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Liofilchem S.R.L. has 37 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 19, 2017
Date Received
Oct 18, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type
510(k)

Other clearances by Liofilchem S.R.L.

  • K261853 — Gepotidacin GEP 10 µg (Jul 23, 2026)
  • K260696 — MTS Gepotidacin 0.016-256 µg/mL (Apr 17, 2026)
  • K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (Oct 2, 2025)
  • K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (Aug 20, 2025)
  • K251879 — Sulopenem SPM 2 µg (Aug 12, 2025)
  • K250885 — Ceftobiprole BPR 5 µg Disc (Jun 23, 2025)
  • K243202 — MTS Ceftobiprole 0.002-32 µg/mL (Jan 30, 2025)
  • K230479 — ComASP Cefiderocol 0.008-128 (May 18, 2023)
  • K211672 — MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL (Oct 20, 2021)
  • K200180 — MTS Omadacycline 0.002 - 32 ug/mL (Mar 20, 2020)

Other clearances for product code JWY

  • K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (Apr 21, 2026)
  • K260696 — MTS Gepotidacin 0.016-256 µg/mL (Apr 17, 2026)
  • K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (Oct 2, 2025)
  • K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin… (Sep 25, 2025)
  • K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with… (Sep 5, 2025)
  • K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin… (Aug 28, 2025)
  • K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (Aug 20, 2025)
  • K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with… (Jun 30, 2025)
  • K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP)… (Jun 20, 2025)
  • K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (Jun 12, 2025)

FDA data resources