epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test— 510(k) K171247
Substantially EquivalentEpocal, Inc.
FDA 510(k) clearance K171247 for epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test, Substantially Equivalent on 2018-01-17. Applicant: Epocal, Inc.. Device class: 2.
Clearance details
- Applicant
- Epocal, Inc.
- Product code
- Code CDS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ottawa, CA
Recent devices under product code CDS
view allMore clearances from Epocal, Inc.
view all- K200107 — epoc Blood Analysis System
- K113726 — EPOC CHLORIDE TEST AND EPOC CREATININE TEST
- K093297 — EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
- K092849 — BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
- K090109 — BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
Data sourced from openFDA. This site is unofficial and independent of the FDA.