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FDA 510(k)

CARBON DIOXIDE LIQUID STABLE REAGENT

K-Number: K070251 · 2007-04-30

ApplicantPointe Scientific, Inc.,
Decision Date2007-04-30
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE LIQUID STABLE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 2007-04-30 under 510(k) number K070251. 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 CARBON DIOXIDE LIQUID STABLE REAGENT?

CARBON DIOXIDE LIQUID STABLE REAGENT is a medical device that received FDA 510(k) clearance on 2007-04-30. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K070251.

When did CARBON DIOXIDE LIQUID STABLE REAGENT receive FDA 510(k) clearance?

CARBON DIOXIDE LIQUID STABLE REAGENT received FDA 510(k) clearance on 2007-04-30, under 510(k) number K070251.

Who is the listed applicant for CARBON DIOXIDE LIQUID STABLE REAGENT?

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

What is the FDA product code for CARBON DIOXIDE LIQUID STABLE REAGENT?

The FDA product code for CARBON DIOXIDE LIQUID STABLE REAGENT is KHS.

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Other records listing Pointe Scientific, 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070207MULTI-ANALYTE CHEMISTRY CALIBRATORK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORSK051646ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH

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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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