Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube
FDA 510(k) K093297 · Epocal, Inc.
510(k) numberK093297
Submission
- Device name
- Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube
- Applicant
- Epocal, Inc.
Ottawa, CA - Received
- October 21, 2009
- Decision date
- June 9, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHP – Acid, Lactic, Enzymatic Method
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1450
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KHP
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|---|---|---|---|
| K130113 | Piccolo Lactate Test SystemKHP · Traditional | Abaxis, Inc. | 03/11/2013SE |
| K113216 | Rapidpoint 500 Blood Gas AnalyerKHP · Traditional | Siemens Healthcare Diagnostics | 05/03/2012SE |
| K112955 | Nova Statstrip Lactate Hospital Meter SystemKHP · Traditional | Nova Biomedical Corporation | 01/05/2012SE |
| K112430 | I-Stat Lactate Test/I-Sat CG4+CARTRIDGEKHP · Traditional | Abbott Pont of Care, Inc. | 12/20/2011SE |
| K100602 | Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsKHP · Traditional | Nova Biomedical Corp. | 08/17/2011SE |
| K013938 | Irma SL Blood Analysis System Lactate CartridgeKHP · Traditional | Diametrics Medical, Inc. | 01/28/2002SE |
| K011478 | I-Stat SystemKHP · Traditional | I-Stat Corp. | 07/02/2001SE |
| K980908 | Lactate Pro SystemKHP · Traditional | Kdk Corp. | 09/11/1998SE |
| K982071 | I-Stat Lactate TestKHP · Traditional | I-Stat Corp. | 06/29/1998SE |
| K971944 | Lactest IKHP · Traditional | Jwt, Inc. | 12/17/1997SE |
More from Jwt, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200107 | epoc Blood Analysis SystemCHL · Special | 06/05/2020SE |
| 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 |
| 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 Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube cleared by the FDA?
Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube (K093297) received a 510(k) decision of Substantially Equivalent on June 9, 2010, 231 days after the submission was received.
What is the product code of K093297?
The FDA product code is KHP – Acid, Lactic, Enzymatic Method, a Class I (low risk) device regulated under 21 CFR 862.1450.