EPOC BLOOD ANALYSIS SYSTEM
FDA 510(k) clearance K061597 · decided 2006-09-27
Clearance details
- K-number
- K061597
- Device name
- EPOC BLOOD ANALYSIS SYSTEM
- Applicant
- Epocal, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-08
- Decision date
- 2006-09-27
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Ottawa, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc H recall (Z-1214-2023) | Siemens Healthcare Diagnostics Inc | 2023-03-03 |
| EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical p recall (Z-0952-2009) | Epocal | 2009-02-06 |