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FDA 510(k)

epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test

K-Number: K171247 · 2018-01-17

ApplicantEpocal, Inc.
Decision Date2018-01-17
Product CodeCDS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test is a medical device manufactured by Epocal, Inc.. It received FDA 510(k) clearance on 2018-01-17 under approval number K171247. The device is classified under product code CDS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test?

epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test is a medical device that received FDA 510(k) clearance on 2018-01-17. It is manufactured by Epocal, Inc.. The 510(k) number is K171247.

When was epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test approved by the FDA?

epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test received FDA 510(k) clearance on 2018-01-17, under approval number K171247.

What company makes epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test?

epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test is manufactured by Epocal, Inc..

What is the FDA product code for epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test?

The FDA product code for epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test is CDS.

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Other Devices by Epocal, Inc.

K200107epoc Blood Analysis System

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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