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FDA 510(k)

CO2

K-Number: K981840 · 1998-06-08

ApplicantAbbott Laboratories
Decision Date1998-06-08
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CO2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-06-08 under 510(k) number K981840. 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 CO2?

CO2 is a medical device that received FDA 510(k) clearance on 1998-06-08. The listed applicant is Abbott Laboratories. The 510(k) number is K981840.

When did CO2 receive FDA 510(k) clearance?

CO2 received FDA 510(k) clearance on 1998-06-08, under 510(k) number K981840.

Who is the listed applicant for CO2?

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

What is the FDA product code for CO2?

The FDA product code for CO2 is KHS.

Other records listing Abbott Laboratories as applicant

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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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