Data / Medical devices / Italy / S.A.L.F. Laboratorio Framacologico
S.A.L.F. Laboratorio Framacologico: FDA-registered device maker in Cenate Scotto Bergamo, Italy, 6 510(k) clearances
S.A.L.F. Laboratorio Framacologico is registered with the FDA (registration 3007685782) in Cenate Scotto Bergamo, Italy. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007685782
- Address
- Via Marconi 2, Cenate Scotto Bergamo, Italy, 24069
- Owner or operator
- S.A.L.F. Spa Laboratorio Farmacologico (10056182)
- Roles
- Manufacturer
- First device listed
- November 13, 2017
- Registered through
- 2026
- Brand names listed
- S.A.L.F.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Perfusion, Kidney, Disposable | KDL | 2 | Manufacturer | accessdata.fda.gov |
| System And Accessories, Isolated Heart, Transport And Preservation | MSB | 2 | Manufacturer | accessdata.fda.gov |
| System, Perfusion, Kidney | KDN | 2 | 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 |
|---|---|---|---|---|---|---|
| September 21, 2023 | K230193 | Servator P Plus SALF Solution | KDN | Substantially Equivalent | S.A.L.F. Spa | accessdata.fda.gov |
| December 20, 2021 | K211842 | Servator M SALF Solution | KDL | Substantially Equivalent | S.A.L.F. Spa | accessdata.fda.gov |
| August 19, 2021 | K202652 | Servator P SALF Solution with THAM | KDN | Substantially Equivalent | S.A.L.F. Spa | accessdata.fda.gov |
| August 14, 2019 | K190063 | Servator C SALF Solution | MSB | Substantially Equivalent | S.A.L.F. Spa | accessdata.fda.gov |
| June 29, 2018 | K180481 | Servator B SALF Solution | KDN | Substantially Equivalent | S.A.L.F. Spa | accessdata.fda.gov |
| October 20, 2017 | K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags | KDL | Substantially Equivalent | S.A.L.F. Spa | accessdata.fda.gov |
Compare with other makers
- All makers of System, Perfusion, Kidney
- All makers of System And Accessories, Isolated Heart, Transport And Preservation
- All makers of Set, Perfusion, Kidney, Disposable
Updated September 21, 2023. 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.