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FDA 510(k)

COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)

K-Number: K980996 · 1998-06-05

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1998-06-05
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1998-06-05 under 510(k) number K980996. 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 (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)?

COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) is a medical device that received FDA 510(k) clearance on 1998-06-05. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K980996.

When did COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) receive FDA 510(k) clearance?

COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) received FDA 510(k) clearance on 1998-06-05, under 510(k) number K980996.

Who is the listed applicant for COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)?

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

What is the FDA product code for COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)?

The FDA product code for COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) is KHS.

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Other records listing Roche Diagnostic Systems, 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.

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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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