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FDA 510(k)

ROCHE REAGENTS REAGENT FOR CO2

K-Number: K844987 · 1985-01-18

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1985-01-18
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE REAGENTS REAGENT FOR CO2 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 1985-01-18 under 510(k) number K844987. 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 ROCHE REAGENTS REAGENT FOR CO2?

ROCHE REAGENTS REAGENT FOR CO2 is a medical device that received FDA 510(k) clearance on 1985-01-18. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K844987.

When did ROCHE REAGENTS REAGENT FOR CO2 receive FDA 510(k) clearance?

ROCHE REAGENTS REAGENT FOR CO2 received FDA 510(k) clearance on 1985-01-18, under 510(k) number K844987.

Who is the listed applicant for ROCHE REAGENTS REAGENT FOR CO2?

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 ROCHE REAGENTS REAGENT FOR CO2?

The FDA product code for ROCHE REAGENTS REAGENT FOR CO2 is KHS.

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Other records listing Roche Diagnostic Systems, 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.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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