Chrysalis Intelligence · Sponsors · Liofilchem s.r.l.

Liofilchem s.r.l.

Roseto Degli Abruzzi, IT · 10 510(k) clearances

Total clearances
10
2020-03-20 → 2026-07-23
Last 12 months
3
Product codes
2
Most recent
2026-07-23
Name variants in FDA filings: Liofilchem / Liofilchem, Inc. / Liofilchem s.r.l.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
JWY 7 2026-04-17
JTN Susceptibility Test Discs, Antimicrobial Class II Microbiology 3 2026-07-23
Filings

All 510(k) clearances (10)

Date K-number Device Code Class Specialty
2026-07-23 K261853 Gepotidacin GEP 10 µg JTN Class II Microbiology
2026-04-17 K260696 MTS Gepotidacin 0.016-256 µg/mL JWY
2025-10-02 K252114 MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL JWY
2025-08-20 K251580 MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) JWY
2025-08-12 K251879 Sulopenem SPM 2 µg JTN Class II Microbiology
2025-06-23 K250885 Ceftobiprole BPR 5 µg Disc JTN Class II Microbiology
2025-01-30 K243202 MTS Ceftobiprole 0.002-32 µg/mL JWY
2023-05-18 K230479 ComASP Cefiderocol 0.008-128 JWY
2021-10-20 K211672 MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL JWY
2020-03-20 K200180 MTS Omadacycline 0.002 - 32 ug/mL JWY