epoc Blood Analysis System
FDA 510(k) K200107 · Epocal, Inc.
510(k) numberK200107
Submission
- Device name
- epoc Blood Analysis System
- Applicant
- Epocal, Inc.
Ottawa, CA - Received
- January 17, 2020
- Decision date
- June 5, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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| K252207 | ABL90 FLEX PLUS System, safeCLINITUBESCHL · Traditional | Radiometer Medicals Aps | 04/10/2026SE |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 05/02/2025SE |
| K240998 | ABL90 FLEX PLUS SystemCHL · Traditional | Radiometer Medicals Aps | 12/13/2024SE |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K221900 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | Nova Biomedical Corporation | 09/29/2023SE |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 09/15/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | Instrumentation Laboratory Company | 08/10/2023SE |
| K211559 | EasyStat 300CHL · Traditional | Medica Corporation | 01/27/2023SE |
| K203790 | GEM Premier 5000CHL · Special | Instrumentation Laboratory CO | 08/20/2021SE |
| K200986 | OPTI® B-Lac CassetteCHL · Traditional | Opti Medical Systems, Inc. | 08/02/2021SE |
More from Opti Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestCDS · Traditional | 01/17/2018SE |
| K113726 | Epoc Chloride Test and Epoc Creatinine TestCGL · Traditional | 10/05/2012SE |
| K093297 | Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeKHP · Traditional | 06/09/2010SE |
| K092849 | Blood Collection Tube Samples for Use with Point of Care Blood AnalyzerCEM · Traditional | 03/30/2010SE |
| K090109 | Blood Gas, Electrolyte and Metabolite Test CardCGA · Traditional | 06/24/2009SE |
| K061597 | Epoc Blood Analysis SystemJGS · Traditional | 09/27/2006SE |
Questions and answers
When was epoc Blood Analysis System cleared by the FDA?
epoc Blood Analysis System (K200107) received a 510(k) decision of Substantially Equivalent on June 5, 2020, 140 days after the submission was received.
What is the product code of K200107?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.