Data / Medical devices / United States / Liofilchem, Inc.
Liofilchem, Inc.: FDA-registered device maker in Waltham, MA, United States, 38 510(k) clearances
Liofilchem, Inc. is registered with the FDA (registration 3013661582) in Waltham, MA, United States. It lists 5 device types. The FDA files 38 510(k) clearances under its listings, the newest dated July 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013661582
- Address
- 465 Waverley Oaks Rd. Suite 317, Waltham, MA, United States, 02452
- Owner or operator
- Liofilchem S.R.L. (10052223)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- June 30, 2016
- Registered through
- 2026
- 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 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Manual Antimicrobial Susceptibility Test Systems | JWY | 2 | Complaint file establishment | accessdata.fda.gov |
| Panels, Test, Susceptibility, Antimicrobial | LTT | 2 | Complaint file establishment | accessdata.fda.gov |
| Susceptibility Test Discs, Antimicrobial | JTN | 2 | Complaint file establishment | accessdata.fda.gov |
| Transport Medium, Notified Per The Vtm Guidance | QMC | 1 | Complaint file establishment | 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
- All makers of Manual Antimicrobial Susceptibility Test Systems
- All makers of Susceptibility Test Discs, Antimicrobial
- All makers of Transport Medium, Notified Per The Vtm Guidance
- All makers of Panels, Test, Susceptibility, Antimicrobial
- All makers of Culture Media, Non-Propagating Transport
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.