Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020710668

FEI Number

3020710668

Entity Name

PREVION SOLUTIONS LLC

City/State/Country

Yorba Linda, CA, US

Establishment Address

22895 Eastpark Drive, Yorba Linda, CA 92887, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Previon Solutions LLC (Owner Number: 10082840)

Owner / Operator Contact Address

22895 Eastpark Drive, Yorba Linda, CA 92887, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K041408

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOX	Automated Occult Blood Analyzer	Hematology	Class 2	864.6550	2024-03-04

Official Correspondent

Sasha Jovanovic

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Previon Solutions LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020710668. Last updated year: 2026. Please use registration number 3020710668 when referencing this establishment in official correspondence.