Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000403749

FEI Number

1000403749

Entity Name

NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER

City/State/Country

Koriyama Fukushima, JP

Establishment Address

1, Shiojima, Fukuhara, Fukuyama, Koriyama Fukushima 963-8061, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Nittobo Medical Co., Ltd. (Owner Number: 9028746)

Owner / Operator Contact Address

1, Shiojima, Fukuhara, Fukuyama, Koriyama, JP-07 963-8061, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

N-ASSAY TIA Apo AI K-ASSAY Apo AI K-ASSAY CRP (Ver.2) K-ASSAY Fibrinogen K-ASSAY Apo B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2008-01-31
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2008-01-31
DFT	Igm, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2016-10-27
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2016-10-27
DER	Alpha-1-Lipoprotein, Antigen, Antiserum, Control	Immunology	Class 2	866.5580	2008-01-31
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2016-10-27
DER	Alpha-1-Lipoprotein, Antigen, Antiserum, Control	Immunology	Class 2	866.5580	2012-04-02
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2025-05-28
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2008-01-31
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2016-10-27
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2016-10-27
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2016-10-27
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-01-31
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2008-01-31
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2008-01-31
GIS	Test, Fibrinogen	Hematology	Class 2	864.7340	2008-01-31
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-01-31
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-01-31
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2008-01-31
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	1998-05-13
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-01-31
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2008-01-31
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2018-09-26
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2008-01-31
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2008-01-31
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2016-10-27
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2008-01-31
DER	Alpha-1-Lipoprotein, Antigen, Antiserum, Control	Immunology	Class 2	866.5580	2008-01-31
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2020-10-23
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2020-10-23
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2016-10-27
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2010-12-03
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2010-12-03
NDY	Test, Cystatin C	Clinical Chemistry	Class 2	862.1225	2010-12-03
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-01-31
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-08-09
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	1997-05-02

Official Correspondent

No official correspondent registered.

US Agent Details

Colin Getty Business: Kamiya Biomedical Company Email: cgetty@k-assay.com Phone: (206) 3905224

Related Public Records

Same Entity

Nittobo Medical Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K852783	Advanced Biomedical Methods, Inc.	SGOT/ALT REAGENT	1985-07-22
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
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2015	ELITech Clinical Systems SAS Zone lndustrielle SEES France	2	ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Z-0009-2009	Roche Diagnostics Corp.	2	Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 20763454122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of soluable transferrin receptor in serum and plasma.
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-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000403749. Last updated year: 2026. Please use registration number 1000403749 when referencing this establishment in official correspondence.