PHC Corporation

FDA Device Registration & Listing · Chiyoda-ku Tokyo, JP · Registration 3014353045

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
3014353045
FEI Number
3014353045
Entity Name
PHC Corporation
City/State/Country
Chiyoda-ku Tokyo, JP
Establishment Address
15F DAI-ICHI LIFE HIBIYA FIRST, 1-13-2 Yurakucho, Chiyoda-ku Tokyo 100-8403, JP
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
PHC Corporation (Owner Number: 9052268)
Owner / Operator Contact Address
2131-1 MINAMIGATA, TOON, JP-38 791-0395, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K072288
PMA Number
N/A

All Registered Proprietary Names

PATHFAST NTproBNP PATHFAST Sample Diluent 1 PATHFAST Myo-II PATHFAST CK-MB-II Contour Next Link 2.4 CONTOUR NEXT Test Strip CONTOUR NEXT Test Strip MCO-50M MCO-170MP PATHFAST hs-cTnI-II CONTOUR NEXT ONE Blood Glucose Monitoring System Contour Next, Contour Next Link, Contour Next One Contour Next Link 2.4 CONTOUR NEXT Test Strip CONTOUR NEXT Test Strip Contour Next Link 2.4 PATHFAST hsCRP Contour Next EZ Blood Glucose Meter PATHFAST D-Dimer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 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
OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown Class 3 N/A 2017-12-19
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-03-16
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-03-16
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-03-16
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2014-08-07
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2014-08-07
PUB Accessory, Assisted Reproduction, Exempt Obstetrics/Gynecology Class 2 884.6120 2017-09-24
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2024-03-28
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2016-11-23
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2016-11-23
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-04-07
OZO Automated Insulin Dosing , Threshold Suspend Unknown Class 3 N/A 2016-08-11
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-11-15
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-08-09
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-08-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-08-09
OZO Automated Insulin Dosing , Threshold Suspend Unknown Class 3 N/A 2020-04-07
MXA System, Test, Breath Nitric Oxide Clinical Toxicology Class 2 862.3080 2014-11-14
MXA System, Test, Breath Nitric Oxide Clinical Toxicology Class 2 862.3080 2015-03-24
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
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2020-11-05
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-11-05
GHH Fibrin Split Products Hematology Class 2 864.7320 2023-11-16

Official Correspondent

No official correspondent registered.

US Agent Details

Steven Hubbard Business: PHC Corporation Of North America Email: Steven.Hubbard@Us.Phchd.Com Phone: (551) 4829284

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
3029973107 PHC Corporation Tako-machi Katori-gun Chiba, JP
1000134386 PHC Corporation TOON Ehime, JP
3004167884 PHC Corporation MIMA Tokushima, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K103836 Siemens Healthcare Diagnostics, Inc. ENZYME II CALIBRATOR 2011-02-16
K103548 Siemens Healthcare Diagnostics, Inc. ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 2011-06-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0102-2021 Siemens Healthcare Diagnostics, Inc. 2
Atellica CH 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): 11097637

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014353045. Last updated year: 2026. Please use registration number 3014353045 when referencing this establishment in official correspondence.
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