Liofilchem S.r.l.
Roseto degli Abruzzi Teramo, IT
LIOFILCHEM S.R.L. appears in FDA device records in Roseto degli Abruzzi Teramo, IT. FDA records list 38 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 38 510(k) clearances for Liofilchem S.r.l. between 2016 and 2026. The busiest year on record is 2018, with 9. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 4 |
| 2017 | 8 |
| 2018 | 9 |
| 2019 | 7 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2025 | 5 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261853 | Gepotidacin GEP 10 µg | JTN | Substantially Equivalent | |
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | JWY | Substantially Equivalent | |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | JWY | Substantially Equivalent | |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | JWY | Substantially Equivalent | |
| K251879 | Sulopenem SPM 2 µg | JTN | Substantially Equivalent | |
| K250885 | Ceftobiprole BPR 5 µg Disc | JTN | Substantially Equivalent | |
| K243202 | MTS Ceftobiprole 0.002-32 µg/mL | JWY | Substantially Equivalent | |
| K230479 | ComASP Cefiderocol 0.008-128 | JWY | Substantially Equivalent | |
| K211672 | MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL | JWY | Substantially Equivalent | |
| K200180 | MTS Omadacycline 0.002 - 32 ug/mL | JWY | Substantially Equivalent | |
| K192345 | MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL | JWY | Substantially Equivalent | |
| K191908 | MTS Imipenem 0.016-256 µg/mL | JWY | Substantially Equivalent | |
| K191809 | MTS Imipenem-relebactam 0.002/4-32/4 µg/mL | JWY | Substantially Equivalent | |
| K190914 | MTS Doxycycline 0.016 - 256 µg/mL | JWY | Substantially Equivalent | |
| K190252 | MTS Gentamicin 0.016 - 256 µg/mL | JWY | Substantially Equivalent | |
| K183527 | MTS Ciprofloxacin 0.002 - 32 µg/mL | JWY | Substantially Equivalent | |
| K183140 | MTS Tetracycline 0.016 - 256 ug/mL | JWY | Substantially Equivalent | |
| K183115 | MTS Levofloxacin 0.002 - 32 µg/mL | JWY | Substantially Equivalent | |
| K182922 | MTS Omadacycline 0.002-32 µg/mL | JWY | Substantially Equivalent | |
| K182557 | MTS Eravacycline 0.002 - 32 µg/mL | JWY | Substantially Equivalent | |
| K181889 | MTS Penicillin 0.002- 32 µg/mL | JWY | Substantially Equivalent | |
| K181708 | MTS Plazomicin 0.016-256 µg/mL | JWY | Substantially Equivalent | |
| K180886 | Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL | JWY | Substantially Equivalent | |
| K180339 | Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL | JWY | Substantially Equivalent | |
| K180330 | Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL | JWY | Substantially Equivalent | |
| K173817 | Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL | JWY | Substantially Equivalent | |
| K173307 | Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL | JWY | Substantially Equivalent | |
| K172542 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. | JWY | Substantially Equivalent | |
| K172109 | Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL | JWY | Substantially Equivalent | |
| K171906 | Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL | JWY | Substantially Equivalent | |
| K170772 | Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL | JWY | Substantially Equivalent | |
| K170892 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL | JWY | Substantially Equivalent | |
| K163517 | Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL | JWY | Substantially Equivalent | |
| K163298 | Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL | JWY | Substantially Equivalent | |
| K162854 | Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml | JWY | Substantially Equivalent | |
| K161175 | Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL | JWY | Substantially Equivalent | |
| K153569 | Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml | JWY | Substantially Equivalent | |
| K153687 | Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL | JWY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012389632 | 3012389632 | LIOFILCHEM S.R.L. | Via Scozia, Zona Industriale, Roseto degli Abruzzi Teramo 64026 IT | 2026 | |
| 3013661582 | 3013661582 | Liofilchem, Inc. | 465 Waverley Oaks Rd. Suite 317, Waltham, MA 02452 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain