Data / Medical devices / United States / Affinity Biosensors
Affinity Biosensors: FDA-registered device maker in Santa Barbara, CA, United States, 1 510(k) clearance
Affinity Biosensors is registered with the FDA (registration 3025772277) in Santa Barbara, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025772277
- Address
- 222 E Canon Perdido St Ste 101, Santa Barbara, CA, United States, 93101
- Owner or operator
- Affinity Biosensors (10091217)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 25, 2024
- Registered through
- 2026
- Brand names listed
- LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | SAN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | LON | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 2, 2024 | K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System | SAN | Substantially Equivalent | Affinity Biosensors | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- All makers of Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Updated April 2, 2024. 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.