Data / Medical devices / United States / Previon Solutions LLC
Previon Solutions LLC: FDA-registered device maker in Yorba Linda, CA, United States, 1 510(k) clearance
Previon Solutions LLC is registered with the FDA (registration 3020710668) in Yorba Linda, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 21, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020710668
- Address
- 22895 Eastpark Drive, Yorba Linda, CA, United States, 92887
- Owner or operator
- Previon Solutions LLC (10082840)
- Roles
- Repackager or relabeler
- First device listed
- March 4, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Occult Blood Analyzer | OOX | 2 | Repackager or relabeler | 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 21, 2004 | K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | OOX | Substantially Equivalent | Polymedco, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 21, 2004. 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.