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FDA 510(k)

EPOC CHLORIDE TEST AND EPOC CREATININE TEST

K-Number: K113726 · 2012-10-05

ApplicantEpocal, Inc.
Decision Date2012-10-05
Product CodeCGL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EPOC CHLORIDE TEST AND EPOC CREATININE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Epocal, Inc.. It received FDA 510(k) clearance on 2012-10-05 under 510(k) number K113726. The device is classified under product code CGL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPOC CHLORIDE TEST AND EPOC CREATININE TEST?

EPOC CHLORIDE TEST AND EPOC CREATININE TEST is a medical device that received FDA 510(k) clearance on 2012-10-05. The listed applicant is Epocal, Inc.. The 510(k) number is K113726.

When did EPOC CHLORIDE TEST AND EPOC CREATININE TEST receive FDA 510(k) clearance?

EPOC CHLORIDE TEST AND EPOC CREATININE TEST received FDA 510(k) clearance on 2012-10-05, under 510(k) number K113726.

Who is the listed applicant for EPOC CHLORIDE TEST AND EPOC CREATININE TEST?

The FDA 510(k) record lists Epocal, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPOC CHLORIDE TEST AND EPOC CREATININE TEST?

The FDA product code for EPOC CHLORIDE TEST AND EPOC CREATININE TEST is CGL.

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Related Devices (Code: CGL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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