Fujirebio Diagnostics, AB

FDA Device Registration & Listing · Gothenburg Vastra Gotaland, SE · Registration 3000125561

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3000125561
FEI Number
3000125561
Entity Name
Fujirebio Diagnostics, AB
City/State/Country
Gothenburg Vastra Gotaland, SE
Establishment Address
Elof Lindalvs Gata 13, Gothenburg Vastra Gotaland 41455, SE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Fujirebio Diagnostics, Inc. (Owner Number: 10022860)
Owner / Operator Contact Address
201 Great Valley Parkway, Malvern, PA 19355, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K101809
PMA Number
N/A

All Registered Proprietary Names

AMH Control Fujirebio Diagnostics Tumor Marker Control

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2019-03-05
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2010-12-02

Official Correspondent

Greg Dickson

US Agent Details

Greg Dickson Business: Fujirebio Diagnostics, Inc. Email: dicksong@fdi.com Phone: (610) 2403888

Related Public Records

Same Entity

Fujirebio Diagnostics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3027273565 Fujirebio Diagnostics AB Molndal Vastra Gotaland, SE
9615837 Fujirebio Europe N.V. GHENT Oost-Vlaanderen, BE
3014643041 Fujirebio Inc. Ube Facility Yamaguchi, JP
1643621 Fujirebio Diagnostics, Inc. Seguin, TX, US
3002895169 Fujirebio Inc. Sagamihara-shi Kanagawa, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K990531 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS 1999-03-12
K982637 Diagnostic Products Corp. IMMULITE PSA CONTROL MODULE, MODEL LPSCM 1998-08-12
K012468 Dade Behring, Inc. MODIFICATION TO N/T PROTEIN CONTROL SL 2001-09-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000125561. Last updated year: 2026. Please use registration number 3000125561 when referencing this establishment in official correspondence.
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