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510(k) K230479

ComASP Cefiderocol 0.008-128 by Liofilchem s.r.l. — Product Code JWY

K230479 is an FDA 510(k) premarket notification submitted by Liofilchem s.r.l. for the device "ComASP Cefiderocol 0.008-128". The FDA issued a decision of Substantially Equivalent on May 18, 2023. 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2023
Date Received
February 22, 2023
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

Other clearances by Liofilchem s.r.l.

  • K260696 — MTS Gepotidacin 0.016-256 µg/mL (April 17, 2026)
  • K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (October 2, 2025)
  • K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (August 20, 2025)
  • K251879 — Sulopenem SPM 2 µg (August 12, 2025)
  • K250885 — Ceftobiprole BPR 5 µg Disc (June 23, 2025)
  • K243202 — MTS Ceftobiprole 0.002-32 µg/mL (January 30, 2025)
  • K211672 — MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL (October 20, 2021)
  • K200180 — MTS Omadacycline 0.002 - 32 ug/mL (March 20, 2020)
  • K192345 — MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL (October 31, 2019)
  • K191908 — MTS Imipenem 0.016-256 µg/mL (September 4, 2019)

Other clearances for product code JWY

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

FDA data resources