Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004529019

FEI Number

3004529019

Entity Name

Tosoh Hi-Tec, Inc.

City/State/Country

Yamaguchi, JP

Establishment Address

1-37 Fukugawa Minami-machi, Shunan-shi, Yamaguchi 746-0042, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TOSOH BIOSCIENCE (Owner Number: 8031673)

Owner / Operator Contact Address

3600 Gantz Road, Grove City, OH 43123, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K071132

PMA Number

N/A

All Registered Proprietary Names

Automated Immunoassay Analyzer AIA-2000 Automated Immunoassay Analyzer AIA-360 Automated Immunoassay Analyzer AIA-900 G11 Variant Elution Buffer No. 3 Tosoh Automated Glycohemoglobin Analyzer HLC-723G11 LA G11 Variant Elution Buffer No. 1 Tosoh Automated Glycohemoglobin Analyzer HLC-723G11 HLC-723G11 TSKgel G11 Variant G11 90 SL G11 Variant Elution Buffer No. 2 HEMOGLOBIN A1c Control SET Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LA G8 F&A2 Calibrator Set TSKgel G8 ?-thal HLC-723G8 G8 90 SL G8 ?-thal Elution Buffer Kit AIA®-CL300 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER AIA®-CL2400 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER AIA®-CL1200 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER HLC-723 GR01 Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 GR01 G8 Variant Elution Buffer No. 3 HbA1c Calibrator Set G8 90 SL Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LA Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 TSKgel G8 Variant HLC-723G8 G8 Variant Elution Buffer No. 1 G8 Variant Elution Buffer No. 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2005-11-14
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2024-03-14
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-03-15
JPD	Hemoglobin A2 Quantitation	Hematology	Class 2	864.7400	2017-02-07
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-05-09
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2025-12-29
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2025-12-29
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2008-12-01
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-12-01

Official Correspondent

Isabelle Lang-Zwosta

US Agent Details

Isabelle Lang-Zwosta Business: Tosoh Bioscience Inc. Email: Isabelle.Lang-Zwosta@Tosoh.com Phone: (615) 8064671

Related Public Records

Same Entity

TOSOH BIOSCIENCE

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8031673	TOSOH CORP.	Chuo-ku Tokyo, JP
9612316	TOSOH AIA, INC.	TOYAMA, JP
3005529799	TOSOH BIOSCIENCE, INC.	Grove City, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171771	Siemens Healthcare Diagnostics, Inc.	ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay	2017-12-04
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004529019. Last updated year: 2026. Please use registration number 3004529019 when referencing this establishment in official correspondence.