Data / Medical devices / Italy / Liofilchem S.R.L.

Liofilchem S.R.L.: FDA-registered device maker in Roseto degli Abruzzi Teramo, Italy, 38 510(k) clearances

Name: Liofilchem S.R.L. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Liofilchem S.R.L. is registered with the FDA (registration 3012389632) in Roseto degli Abruzzi Teramo, Italy. It lists 5 device types. The FDA files 38 510(k) clearances under its listings, the newest dated July 23, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012389632
Address: Via Scozia, Zona Industriale, Roseto degli Abruzzi Teramo, Italy, 64026
Owner or operator: Liofilchem S.R.L. (10052223)
Roles: Complaint file establishment, Manufacturer
First device listed: June 30, 2016
Registered through: 2027
Brand names listed: Ceftobiprole BPR 5 ug DISC, ComASP Cefiderocol 008-128, Gepotidacin GEP 10ug, MTS Ampicillin-sulbactam 016/008-256/128 ug/mL, MTS Aztreonam-Avibactam 016/4 - 256/4 ug/ml., MTS Ceflobiprole 002-32 ug/ml, MTS Ciprofloxacin 002 - 32 ug/mL, MTS Doxycycline 016-256 ug/mL and more

Devices it lists

Device	Product code	Class	Role	Source
Culture Media, Non-Propagating Transport	JSM	1	Manufacturer	accessdata.fda.gov
Manual Antimicrobial Susceptibility Test Systems	JWY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Panels, Test, Susceptibility, Antimicrobial	LTT	2	Manufacturer	accessdata.fda.gov
Susceptibility Test Discs, Antimicrobial	JTN	2	Manufacturer	accessdata.fda.gov
Transport Medium, Notified Per The Vtm Guidance	QMC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 23, 2026	K261853	Gepotidacin GEP 10 µg	JTN	Substantially Equivalent	Liofilchem, Inc.	accessdata.fda.gov
April 17, 2026	K260696	MTS Gepotidacin 0.016-256 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
October 2, 2025	K252114	MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
August 20, 2025	K251580	MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
August 12, 2025	K251879	Sulopenem SPM 2 µg	JTN	Substantially Equivalent	Liofilchem	accessdata.fda.gov
June 23, 2025	K250885	Ceftobiprole BPR 5 µg Disc	JTN	Substantially Equivalent	Liofilchem, Inc.	accessdata.fda.gov
January 30, 2025	K243202	MTS Ceftobiprole 0.002-32 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
May 18, 2023	K230479	ComASP Cefiderocol 0.008-128	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
October 20, 2021	K211672	MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
April 6, 2020	K200308	MTS Lefamulin 0.016- 256 µg/mL	JWY	Substantially Equivalent	Liofilchem S. R. 1.	accessdata.fda.gov
October 31, 2019	K192345	MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
September 4, 2019	K191908	MTS Imipenem 0.016-256 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
August 23, 2019	K191809	MTS Imipenem-relebactam 0.002/4-32/4 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
May 29, 2019	K190914	MTS Doxycycline 0.016 - 256 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
March 22, 2019	K190252	MTS Gentamicin 0.016 - 256 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
March 19, 2019	K183527	MTS Ciprofloxacin 0.002 - 32 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
January 11, 2019	K183140	MTS Tetracycline 0.016 - 256 ug/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
December 20, 2018	K183115	MTS Levofloxacin 0.002 - 32 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
December 14, 2018	K182922	MTS Omadacycline 0.002-32 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
November 2, 2018	K182557	MTS Eravacycline 0.002 - 32 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
September 13, 2018	K181889	MTS Penicillin 0.002- 32 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
July 31, 2018	K181708	MTS Plazomicin 0.016-256 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
May 18, 2018	K180886	Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
April 4, 2018	K180339	Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
March 15, 2018	K180330	Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
February 28, 2018	K173817	Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
December 19, 2017	K173307	Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
October 23, 2017	K172542	Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
September 27, 2017	K172109	Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
August 1, 2017	K171906	Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
June 7, 2017	K170772	Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
May 25, 2017	K170892	Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
March 14, 2017	K163517	Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
February 22, 2017	K163298	Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
December 19, 2016	K162854	Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
July 12, 2016	K161175	Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
June 22, 2016	K153569	Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov
March 31, 2016	K153687	Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL	JWY	Substantially Equivalent	Liofilchem s.r.l.	accessdata.fda.gov

Compare with other makers

Updated July 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.