Data / Medical devices / Canada / Epocal, Inc.
Epocal, Inc.: FDA-registered device maker in Ottawa Ontario, Canada, 7 510(k) clearances
Epocal, Inc. is registered with the FDA (registration 3004959793) in Ottawa Ontario, Canada. It lists 13 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 5, 2020. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004959793
- Address
- 2060 Walkley Road, Ottawa Ontario, Canada, K1G-3P5
- Owner or operator
- SIEMENS HEALTHCARE DIAGNOSTICS INC. (9096044)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 7, 2000
- Registered through
- 2026
- Brand names listed
- Atellica Data Manager (ADM), Atellica® Connect, Atellica® Connect SE, CentraLink, EDM, POCcelerator, RAPIDComm, UniPOC and more
Devices it lists
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 |
| January 17, 2018 | K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | CDS | Substantially Equivalent | Epocal, Inc. | accessdata.fda.gov |
| October 5, 2012 | K113726 | EPOC CHLORIDE TEST AND EPOC CREATININE TEST | CGL | Substantially Equivalent | Epocal, Inc. | accessdata.fda.gov |
| June 9, 2010 | K093297 | EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE | KHP | Substantially Equivalent | Epocal, Inc. | accessdata.fda.gov |
| March 30, 2010 | K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER | CEM | Substantially Equivalent | Epocal, Inc. | accessdata.fda.gov |
| June 24, 2009 | K090109 | BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD | CGA | Substantially Equivalent | Epocal, Inc. | accessdata.fda.gov |
| September 27, 2006 | K061597 | EPOC BLOOD ANALYSIS SYSTEM | JGS | Substantially Equivalent | Epocal, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 13, 2013 | 65126 | Class II | Terminated | epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium, Ionized Calcium, Glucose, Lactate and Hematocrit. | This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl). Specifically, after a period of storage of three (3) to four (4) months, the Glucose sensor may report low results at the | accessdata.fda.gov |
| June 28, 2011 | 61147 | Class II | Terminated | epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system | Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results. | accessdata.fda.gov |
| October 16, 2008 | 50209 | Not yet classified | Terminated | EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the laboratory or at the poin | elevated range of potassium levels | accessdata.fda.gov |
Compare with other makers
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- All makers of Glucose Oxidase, Glucose
- All makers of Electrode, Ion Specific, Calcium
- All makers of Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- All makers of Device, Hematocrit Measuring
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.