Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012817228

FEI Number

3012817228

Entity Name

Epocal Inc

City/State/Country

Ottawa Ontario, CA

Establishment Address

855 Brookfield Road, Ottawa Ontario K1V 2S5, CA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

SIEMENS HEALTHCARE DIAGNOSTICS INC. (Owner Number: 9096044)

Owner / Operator Contact Address

Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue, Tarrytown, NY 10591, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200107

PMA Number

N/A

All Registered Proprietary Names

epoc Reader (refurbished) (10736404/HR-1R04-00-00) epoc Reader (10736398/HR-1002-00-00) epoc Host (refurbished) (10736395/HH-1R09-JP-JP) epoc Host (10736423/HH-0010-JP-JP) epoc Host (refurbished) (10736429/HH-0R03-CA-00) epoc Host (10736390/HH-1009-JP-JP) epoc Host (refurbished) (10736394/HH-1R09-CA-00) epoc Host (10736427/HH-0005-CA-00) epoc Host (refurbished) (10736419/HH-0R05-00-00) epoc Host (refurbished) (10736428/HH-0R05-CA-00) epoc Host (refurbished) (10736415/HH-0R03-XU-00) epoc Host (10736414/HH-0003-XU-00) epoc Host (refurbished) (10736412/HH-0R03-00-00) epoc Host (10736387/HH-1009-00-00) epoc Host (10736420/HH-0005-XU-00) epoc Host (10736388/HH-1009-CA-00) epoc Host (refurbished) (10736433/HH-1R09-CN-ZH) epoc Host (refurbished) (10736421/HH-0R05-XU-00) epoc Host (10736418/HH-0005-00-00) epoc Host (refurbished) (10736393/HH-1R09-00-00) epoc Host (refurbished) (10736424/HH-0R10-JP-JP) epoc Host (10736411/HH-0003-00-00) epoc Host (10736389/HH-1009-CN-ZH) epoc Host (refurbished) (10736426/HH-0R03-XU-JP) epoc Reader (refurbished) (10736401/HR-1R02-00-00) epoc NXS Host - 5553 (11413475) epoc NXS Host - 5553CA (11413506) epoc® Blood Analysis System epoc NXS Host - 544DRoW (11413518) epoc NXS Host - 4A50JP (11413498) epoc NXS Host - 4D58MX (11413517) epoc NXS Host - 0000 (11413497) epoc BGEM Test Cards (w/ CREA & CL) (10736382) epoc BGEM Test Cards (w/ BUN & TCO2) (10736515)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2018-02-20
JPI	Device, Hematocrit Measuring	Hematology	Class 2	864.6400	2018-02-20
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2018-02-20
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2018-02-20
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2018-02-20
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2020-06-11
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2020-06-11
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2020-06-11
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2020-06-11
JPI	Device, Hematocrit Measuring	Hematology	Class 2	864.6400	2020-06-11
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2020-06-11
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2020-06-11
CDS	Electrode, Ion Specific, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2020-06-11
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2020-06-11
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2020-06-11
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2020-06-11

Official Correspondent

No official correspondent registered.

US Agent Details

Felix Akinrinola Email: felix.akinrinola@siemens-healthineers.com Phone: (781) 8561738

Related Public Records

Same Entity

SIEMENS HEALTHCARE DIAGNOSTICS INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011194542	Siemens Healthcare GmbH	Berlin, DE
3009448641	Siemens Healthcare Diagnostics, Inc.	Mishawaka, IN, US
3004959793	EPOCAL, INC.	Ottawa Ontario, CA
9610633	SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD	SUDBURY Suffolk, GB
3002637618	Siemens Healthcare Diagnostics Inc	East Walpole, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K760969	Instrumentation Laboratory CO	PH/BLOOD GAS SYSTEM	1977-01-12
K820744	Instrumentation Laboratory CO	IL MODEL 1301, PH BLOOD GAS SYSTEM	1982-04-15
K811310	Chem-Elec, Inc.	SODIUM/POTASSIUM REAGENT KITS	1981-07-10
K013373	Roche Diagnostics Corp.	OMNI C ANALYZER	2001-11-02
K840557	Shaban Mfg. Co.	REAGENTS & STANDARDS IL 501 NA/K	1984-04-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2008	Radiometer America Inc	2	Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
Z-0778-2007	Instrumentation Laboratory Co.	2	GEM Premier 4000 Laboratory Analyzer
Z-0845-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use
Z-0846-03	Instrumentation Laboratory Co.	2	GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use
Z-0102-2014	Siemens Healthcare Diagnostics Inc	2	Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012817228. Last updated year: 2026. Please use registration number 3012817228 when referencing this establishment in official correspondence.