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FDA 510(k)

BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD

K-Number: K090109 · 2009-06-24

ApplicantEpocal, Inc.
Decision Date2009-06-24
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD is the device name listed in this FDA 510(k) record. The listed applicant is Epocal, Inc.. It received FDA 510(k) clearance on 2009-06-24 under 510(k) number K090109. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD?

BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD is a medical device that received FDA 510(k) clearance on 2009-06-24. The listed applicant is Epocal, Inc.. The 510(k) number is K090109.

When did BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD receive FDA 510(k) clearance?

BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD received FDA 510(k) clearance on 2009-06-24, under 510(k) number K090109.

Who is the listed applicant for BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD?

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 GAS, ELECTROLYTE AND METABOLITE TEST CARD?

The FDA product code for BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD is CGA.

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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 TUBEK092849BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZERK061597EPOC BLOOD ANALYSIS SYSTEM

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Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

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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