epoc Blood Analysis System
FDA 510(k) clearance K200107 · decided 2020-06-05
Clearance details
- K-number
- K200107
- Device name
- epoc Blood Analysis System
- Applicant
- Epocal, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-01-17
- Decision date
- 2020-06-05
- Days to decision
- 140 days
- Clearance type
- Special
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Ottawa, CA
- Third-party review
- No
- Expedited review
- No
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