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FDA 510(k)

COBAS INTEGRA CARBON DIOXIDE ASSAY

K-Number: K031879 · 2003-07-17

ApplicantRoche Diagnostics Corp.
Decision Date2003-07-17
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA CARBON DIOXIDE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2003-07-17 under 510(k) number K031879. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS INTEGRA CARBON DIOXIDE ASSAY?

COBAS INTEGRA CARBON DIOXIDE ASSAY is a medical device that received FDA 510(k) clearance on 2003-07-17. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K031879.

When did COBAS INTEGRA CARBON DIOXIDE ASSAY receive FDA 510(k) clearance?

COBAS INTEGRA CARBON DIOXIDE ASSAY received FDA 510(k) clearance on 2003-07-17, under 510(k) number K031879.

Who is the listed applicant for COBAS INTEGRA CARBON DIOXIDE ASSAY?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS INTEGRA CARBON DIOXIDE ASSAY?

The FDA product code for COBAS INTEGRA CARBON DIOXIDE ASSAY is KHS.

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Other records listing Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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Related Devices (Code: KHS)

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.

K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc.K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.K131546AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann

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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