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FDA 510(k)

VITROS CHEMISTRY PRODUCTS ECO2 SLIDES

K-Number: K120765 · 2012-10-24

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2012-10-24
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS CHEMISTRY PRODUCTS ECO2 SLIDES is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2012-10-24 under 510(k) number K120765. 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 VITROS CHEMISTRY PRODUCTS ECO2 SLIDES?

VITROS CHEMISTRY PRODUCTS ECO2 SLIDES is a medical device that received FDA 510(k) clearance on 2012-10-24. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K120765.

When did VITROS CHEMISTRY PRODUCTS ECO2 SLIDES receive FDA 510(k) clearance?

VITROS CHEMISTRY PRODUCTS ECO2 SLIDES received FDA 510(k) clearance on 2012-10-24, under 510(k) number K120765.

Who is the listed applicant for VITROS CHEMISTRY PRODUCTS ECO2 SLIDES?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS CHEMISTRY PRODUCTS ECO2 SLIDES?

The FDA product code for VITROS CHEMISTRY PRODUCTS ECO2 SLIDES is KHS.

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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.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

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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