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FDA 510(k)

ABBOTT SPECTRUM(R) BICARBONATE REAGENT

K-Number: K884821 · 1988-12-27

ApplicantAbbott Laboratories
Decision Date1988-12-27
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT SPECTRUM(R) BICARBONATE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-12-27 under 510(k) number K884821. 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 ABBOTT SPECTRUM(R) BICARBONATE REAGENT?

ABBOTT SPECTRUM(R) BICARBONATE REAGENT is a medical device that received FDA 510(k) clearance on 1988-12-27. The listed applicant is Abbott Laboratories. The 510(k) number is K884821.

When did ABBOTT SPECTRUM(R) BICARBONATE REAGENT receive FDA 510(k) clearance?

ABBOTT SPECTRUM(R) BICARBONATE REAGENT received FDA 510(k) clearance on 1988-12-27, under 510(k) number K884821.

Who is the listed applicant for ABBOTT SPECTRUM(R) BICARBONATE REAGENT?

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 ABBOTT SPECTRUM(R) BICARBONATE REAGENT?

The FDA product code for ABBOTT SPECTRUM(R) BICARBONATE REAGENT is KHS.

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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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