# Liofilchem s.r.l.

- Location (FDA's records): Roseto Degli Abruzzi, IT
- FDA decisions: 38 (2016–2026): 38 510(k) clearances
- Names in FDA's records: Liofilchem s.r.l. (35); Liofilchem, Inc. (2); Liofilchem (1)
- Product codes: JWY (35), JTN (3)
- 510(k) review time since 2016: median 62 days, against 61 for FDA's reviews in the same codes and years (20 of 37 faster)
- Predicates its devices cite: 3 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K153687: Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL (2016), cited by 3

## Recent decisions
- 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)

Source page: https://510kreport.com/company/liofilchem