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FDA 510(k)

DEMAND C02

K-Number: K841726 · 1984-06-07

ApplicantCooper Biomedical, Inc.
Decision Date1984-06-07
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DEMAND C02 is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Biomedical, Inc.. It received FDA 510(k) clearance on 1984-06-07 under 510(k) number K841726. 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 DEMAND C02?

DEMAND C02 is a medical device that received FDA 510(k) clearance on 1984-06-07. The listed applicant is Cooper Biomedical, Inc.. The 510(k) number is K841726.

When did DEMAND C02 receive FDA 510(k) clearance?

DEMAND C02 received FDA 510(k) clearance on 1984-06-07, under 510(k) number K841726.

Who is the listed applicant for DEMAND C02?

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

What is the FDA product code for DEMAND C02?

The FDA product code for DEMAND C02 is KHS.

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Other records listing Cooper Biomedical, 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.

K863868IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANTK864512IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTOK863301DEMAND TOTAL PROTEINK861926WORTHINGTON HDL PRECIPITATING REAGENT SETK854130DEMAND ETHYL ALCOHOLK853949DEMAND ACID PHOSPHATASE REAGENT

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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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