Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029973107

FEI Number

3029973107

Entity Name

PHC Corporation

City/State/Country

Tako-machi Katori-gun Chiba, JP

Establishment Address

1460-6 Aza-Mitodai, Mito, Tako-machi Katori-gun Chiba 2892247, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

PHC Corporation (Owner Number: 9052268)

Owner / Operator Contact Address

2131-1 MINAMIGATA, TOON, JP-38 791-0395, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K083412

PMA Number

N/A

All Registered Proprietary Names

PATHFAST D-Dimer PATHFAST Sample Diluent 1 PATHFAST Myo-II PATHFAST CK-MB-II PATHFAST hs-cTnI-II PATHFAST hsCRP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GHH	Fibrin Split Products	Hematology	Class 2	864.7320	2023-11-16
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2023-11-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2023-11-16
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2023-11-16
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2024-03-28
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2023-11-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2023-11-16

Official Correspondent

No official correspondent registered.

US Agent Details

Timothy Huang Email: tim.huang@us.phchd.com Phone: (757) 5280196

Related Public Records

Same Entity

PHC 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
9616263	PHC Corporation	Ora-gun Gunma, JP
1000134386	PHC Corporation	TOON Ehime, JP
3014353045	PHC Corporation	Chiyoda-ku Tokyo, JP
3004167884	PHC Corporation	MIMA Tokushima, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083412	Mitsubishi Kagaku Iatron	PATHFAST HSCRP	2009-03-09
K890399	American Bioproducts Co.	MODIFIED D-DI-TEST KIT	1989-02-07
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2012	Tcoag Us, Incorporated	2	Minutex D-Dimer ; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1 276 9800, Fax: (353) 1 276 9888, Web: www.trinitybiotech.com Minutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer.
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.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

Similar Registrations

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9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
9612316	TOSOH AIA, INC.	TOYAMA, JP
2245451	DIAGNOSTICA STAGO, INC.	PARSIPPANY, NJ, US
3006198300	Diamond Diagnostics Inc.	Budapest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029973107. Last updated year: 2026. Please use registration number 3029973107 when referencing this establishment in official correspondence.