Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013661582

FEI Number

3013661582

Entity Name

Liofilchem, Inc.

City/State/Country

Waltham, MA, US

Establishment Address

465 Waverley Oaks Rd. Suite 317, Waltham, MA 02452, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Liofilchem S.R.L. (Owner Number: 10052223)

Owner / Operator Contact Address

Via Scozia, Zona Industriale, Roseto degli Abruzzi, IT-TE 64026, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170892

PMA Number

N/A

All Registered Proprietary Names

MTSLevofloxacin 002-32 ug/mL MTS Gepotidacin 016-256 ug/mL MTS (MIC Test Strip) Meropenem-vaborbactam 016/8-256/8 ?g/mL MTS (MIC Test Strip) Meropenem 002-32 ?g/mL MTS Piperacillin-tazobactam 0016/4-256/4 ug/mL MTS Aztreonam-Avibactam 016/4 - 256/4 ug/ml. MTS Imipenem 016 - 256 ug/mL MTS(MIC Test Strip) Plazomicin 016-256 ?g/mL MTS (MIC Test Strip) Omadacycline 002-32 ?g/mL MTS (MIC Test Strip) Ceftazidime-avibactam 016/4-256/4 ?g/mL MTS Gentamicin 016 - 256 ug/mL MTS Sulbactam-Durlobactam 004/4-64/4 ug 1mL (SUD) MTS (MIC Test Strip) Eravacycline 002-32 ?g/mL MTS Ampicillin-sulbactam 016/008-256/128 ug/mL MTS (MIC Test Strip) Delafloxacin 002-32 ?g/mL MTS Tetracycline 016 - 256 ug/mL MTS (MIC Test Strip) Vancomycin 016-256 ?g/mL MTS Ceflobiprole 002-32 ug/ml MTS (MIC Test Strip) Linezolid 016-256 ?g/mL Sulopenem disc 2 ug MTS (MIC Test Strip) Penicillin G 002-32 ?g/mL MTS Imipenem-relebactam 002/4 - 32/4 ug/mL MTS (MIC Test Strip) Clindamycin 016-256 ?g/mL MTS (MIC Test Strip) Ceftazidime 016-256 ?g/mL ComASP Cefiderocol 008-128 Ceftobiprole BPR 5 ug DISC MTS Ciprofloxacin 002 - 32 ug/mL MTS Doxycycline 016-256 ug/mL MTS (MIC Test Strip) Tedizolid 002-32 ?g/mL MTS (MIC Test Strip) Azithromycin 016-256 ?g/mL MTS (MIC Test Strip) Telavancin 016-256 ?g/mL MTS (MIC Test Strip) Tedizolid 002-32 ?g/mL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-12-21
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2026-04-27
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-12-20
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-01-19
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2021-10-21
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2025-12-20
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-09-06
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-08-03
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-12-14
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-05-22
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-03-22
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2025-08-26
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-11-02
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-11-01
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-08-01
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-01-11
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2016-06-30
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2025-03-17
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-04-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2025-09-02
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-09-14
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-08-23
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-06-13
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-02-27
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2023-05-26
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	Class 2	866.1640	2023-05-26
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2025-07-03
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-03-20
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2019-05-30
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-05-22
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2018-04-05
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-03-24
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	Class 2	866.1640	2017-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Liofilchem S.R.L.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012389632	LIOFILCHEM S.R.L.	Roseto degli Abruzzi Teramo, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K944753	Radiometer America, Inc.	SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP	1995-02-24
K002664	Hardy Diagnostics	HARDYDISK LEVOFLOXACIN, 5MCG	2000-10-26
K010508	Pasco Laboratories, Inc.	PASCO MIC AND MIC/ID PANELS	2001-04-23
K111394	Siemens Healthcare Diagnostics, Inc.	MICROSCAN MICROSTEP	2011-06-22

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1530126	Remel Cleveland, A Division of Remel Inc.	Oakwood Village, OH, US
8021914	TREK DIAGNOSTIC SYSTEMS, LTD.	East Grinstead West Sussex, GB
3012389632	LIOFILCHEM S.R.L.	Roseto degli Abruzzi Teramo, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013661582. Last updated year: 2026. Please use registration number 3013661582 when referencing this establishment in official correspondence.