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FDA 510(k)

BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER

K-Number: K092849 · 2010-03-30

ApplicantEpocal, Inc.
Decision Date2010-03-30
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Epocal, Inc.. It received FDA 510(k) clearance on 2010-03-30 under 510(k) number K092849. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER?

BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER is a medical device that received FDA 510(k) clearance on 2010-03-30. The listed applicant is Epocal, Inc.. The 510(k) number is K092849.

When did BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER receive FDA 510(k) clearance?

BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER received FDA 510(k) clearance on 2010-03-30, under 510(k) number K092849.

Who is the listed applicant for BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER?

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 BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER?

The FDA product code for BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER is CEM.

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Other records listing Epocal, Inc. as applicant

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.

K200107epoc Blood Analysis SystemK171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestK113726EPOC CHLORIDE TEST AND EPOC CREATININE TESTK093297EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEK090109BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARDK061597EPOC BLOOD ANALYSIS SYSTEM

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Related Devices (Code: CEM)

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.

K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche DiagnosticsK241037ABL90 FLEX PLUS SystemRadiometer Medicals ApsK220396EasyStat 300Medica CorporationK230890ISE ElectrodesRandox Laboratories, Ltd.K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.

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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