Data / Medical devices / Italy / Interlab S.R.L.
Interlab S.R.L.: FDA-registered device maker in ROME Lazio, Italy, 1 510(k) clearance
Interlab S.R.L. is registered with the FDA (registration 3003961883) in ROME Lazio, Italy. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 13, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003961883
- Address
- Via Rina Monti N.26, ROME Lazio, Italy, 00155
- Owner or operator
- SEBIA (8023024)
- Roles
- Manufacturer
- First device listed
- December 5, 2016
- Registered through
- 2026
- Brand names listed
- Interlab G26 Electrophoresis System Immunofixation Electrophoresis
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrophoretic, Protein Fractionation | CEF | 1 | Manufacturer | accessdata.fda.gov |
| Immunoelectrophoretic, Immunoglobulins, (G, A, M) | CFF | 2 | Manufacturer | accessdata.fda.gov |
| Kappa, Antigen, Antiserum, Control | DFH | 2 | Manufacturer | accessdata.fda.gov |
| Lambda, Antigen, Antiserum, Control | DEH | 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 |
|---|---|---|---|---|---|---|
| October 13, 2011 | K103757 | IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT | CFF | Substantially Equivalent | Grifols | accessdata.fda.gov |
Compare with other makers
- All makers of Electrophoretic, Protein Fractionation
- All makers of Kappa, Antigen, Antiserum, Control
- All makers of Lambda, Antigen, Antiserum, Control
- All makers of Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Updated October 13, 2011. 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.