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FDA 510(k)

AU BICARBONATE REAGENT

K-Number: K131546 · 2013-10-09

ApplicantBeckman Coulter Ireland, Inc.
Decision Date2013-10-09
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AU BICARBONATE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter Ireland, Inc.. It received FDA 510(k) clearance on 2013-10-09 under 510(k) number K131546. 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 AU BICARBONATE REAGENT?

AU BICARBONATE REAGENT is a medical device that received FDA 510(k) clearance on 2013-10-09. The listed applicant is Beckman Coulter Ireland, Inc.. The 510(k) number is K131546.

When did AU BICARBONATE REAGENT receive FDA 510(k) clearance?

AU BICARBONATE REAGENT received FDA 510(k) clearance on 2013-10-09, under 510(k) number K131546.

Who is the listed applicant for AU BICARBONATE REAGENT?

The FDA 510(k) record lists Beckman Coulter Ireland, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AU BICARBONATE REAGENT?

The FDA product code for AU BICARBONATE REAGENT is KHS.

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Other records listing Beckman Coulter Ireland, Inc. 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.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 WassermannK111960ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORSElitechgroup

Official Source

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