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FDA 510(k)

CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL

K-Number: K071340 · 2007-10-05

ApplicantThermofisher Scientific OY
Decision Date2007-10-05
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL is the device name listed in this FDA 510(k) record. The listed applicant is Thermofisher Scientific OY. It received FDA 510(k) clearance on 2007-10-05 under 510(k) number K071340. 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 (CO2), SCAL, NORTROL AND ABTROL?

CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL is a medical device that received FDA 510(k) clearance on 2007-10-05. The listed applicant is Thermofisher Scientific OY. The 510(k) number is K071340.

When did CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL receive FDA 510(k) clearance?

CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL received FDA 510(k) clearance on 2007-10-05, under 510(k) number K071340.

Who is the listed applicant for CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL?

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

What is the FDA product code for CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL?

The FDA product code for CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL is KHS.

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Other records listing Thermofisher Scientific OY 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.

K110035INDIKOK073295UREA/BUN, SCAL, NORTROL, ABTROLK073612URIC ACID (AOX), SCAL, NORTROL, ABTROLK073191ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROLK073355CALCIUM, SCAL, NORTROL, ABTROLK070824CREATININE (ENZYMATIC)

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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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