Company ยท CA
Epocal, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2020. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CGA | Glucose Oxidase, Glucose | 3 |
| CEM | Electrode, Ion Specific, Potassium | 2 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 1 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| KHP | Acid, Lactic, Enzymatic Method | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2020 | K200107 | epoc Blood Analysis System Epocal, Inc., CA | CHL |
| Jan 17, 2018 | K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test Epocal, Inc., CA | CDS |
| Oct 5, 2012 | K113726 | EPOC CHLORIDE TEST AND EPOC CREATININE TEST Epocal, Inc., CA | CGL |
| Jun 9, 2010 | K093297 | EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE Epocal, Inc., CA | KHP |
| Mar 30, 2010 | K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER Epocal, Inc., CA | CEM |
| Jun 24, 2009 | K090109 | BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD Epocal, Inc., CA | CGA |
| Sep 27, 2006 | K061597 | EPOC BLOOD ANALYSIS SYSTEM Epocal, Inc., CA | JGS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2013 | Epocal 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. Terminated |
CGA | K090109 K093297 |
| Jul 19, 2012 | Epocal Inc 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 Terminated |
CGA | K090109 |
| Feb 6, 2009 | Epocal 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 labo Terminated |
CEM | K061597 |