Data / Medical devices / Canada / Epocal Inc

Epocal Inc: FDA-registered device maker in Ottawa Ontario, Canada, 2 510(k) clearances

Name: Epocal Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Epocal Inc is registered with the FDA (registration 3012817228) in Ottawa Ontario, Canada. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 5, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012817228
Address: 855 Brookfield Road, Ottawa Ontario, Canada, K1V 2S5
Owner or operator: SIEMENS HEALTHCARE DIAGNOSTICS INC. (9096044)
Roles: Manufacturer, Specification developer
First device listed: February 20, 2018
Registered through: 2026
Brand names listed: epoc BGEM Test Cards (w/ BUN & TCO2) (10736515), epoc BGEM Test Cards (w/ CREA & CL) (10736382), epoc Host (10736387/HH-1009-00-00), epoc Host (10736388/HH-1009-CA-00), epoc Host (10736389/HH-1009-CN-ZH), epoc Host (10736390/HH-1009-JP-JP), epoc Host (10736411/HH-0003-00-00), epoc Host (10736414/HH-0003-XU-00) and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Lactic, Enzymatic Method	KHP	1	Manufacturer, Specification developer	accessdata.fda.gov
Device, Hematocrit Measuring	JPI	2	Manufacturer, Specification developer	accessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	2	Manufacturer, Specification developer	accessdata.fda.gov
Electrode, Ion Based, Enzymatic, Creatinine	CGL	2	Manufacturer, Specification developer	accessdata.fda.gov
Electrode, Ion Specific, Calcium	JFP	2	Manufacturer, Specification developer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Manufacturer, Specification developer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Manufacturer, Specification developer	accessdata.fda.gov
Electrode, Ion Specific, Urea Nitrogen	CDS	2	Manufacturer, Specification developer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Manufacturer, Specification developer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Manufacturer, Specification developer	accessdata.fda.gov
Ph Rate Measurement, Carbon-Dioxide	JFL	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 5, 2020	K200107	epoc Blood Analysis System	CHL	Substantially Equivalent	Epocal, Inc.	accessdata.fda.gov
September 27, 2006	K061597	EPOC BLOOD ANALYSIS SYSTEM	JGS	Substantially Equivalent	Epocal, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 5, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.