Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003522182

FEI Number

3003522182

Entity Name

FUJIFILM Healthcare Manufacturing Corporation MIE Office

City/State/Country

Komono-cho, Mie-gun, JP

Establishment Address

2613-2, Oaza Ogohara, Komono-cho, Mie-gun 510-1222, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FUJIFILM Wako Pure Chemical Corporation (Owner Number: 8030234)

Owner / Operator Contact Address

1-2 Doshomachi 3-Chome, Chuo-Ku, JP-27 540-8605, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K030320

PMA Number

N/A

All Registered Proprietary Names

L-Type HDL-C Reagent Complement Control CH50 Calibrator AUTOKIT CH50 Multi-Calibrator Lipids HR SERIES NEFA-HR2 Solvent A HR SERIES NEFA-HR2 Solvent B HR SERIES NEFA-HR2 Color Reagent B HR SERIES NEFA-HR2 Color Reagent A NEFA Linearity Material uTASWako AFP-L3 Sample Dilution Buffer uTASWako DCP Control L and H uTASWako AFP-L3 Immunological Test System uTASWako AFP-L3 Control L and H uTASWako i30 Immunoanalyzer System uTASWako DCP Calibrator Set uTASWako DCP Immunological Test System uTASWako AFP-L3 Calibrator Set uTASWako Chip Cassette uTASWako Wash Solution Autokit Micro Albumin Control Set Autokit Micro Albumin Calibrator Set Autokit Micro Albumin Microalbumin Controls Alinity c Microalbumin Calibrators Alinity c Microalbumin Reagent Kit Microalbumin Calibrators Microalbumin Alinity c Microalbumin Controls

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2007-02-23
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-02-23
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-18
DAE	Complement C9, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-01-18
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2006-01-25
JLH	Titrimetric, Fatty Acids	Clinical Chemistry	Class 1	862.1290	2007-01-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-02-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-02-28
OAU	Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma	Immunology	Class 2	866.6030	2011-02-28
NSF	Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment	Immunology	Class 2	866.6030	2011-02-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2011-02-28
OUE	Micro Total Analysis Instrument System	Clinical Chemistry	Class 2	862.2570	2011-02-28
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2006-03-01
JIQ	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2006-03-01
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2006-03-01

Official Correspondent

No official correspondent registered.

US Agent Details

Randy Vader Business: FUJIFILM Healthcare Americas Corporation Email: randy.vader@fujifilm.com Phone: (360) 3566821

Related Public Records

Same Entity

FUJIFILM Wako Pure Chemical Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003419906	FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)	Amagasaki-shi Hyogo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Z-0033-2022	Sentinel CH SpA Via Robert Koch	2	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003522182. Last updated year: 2026. Please use registration number 3003522182 when referencing this establishment in official correspondence.