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FDA 510(k)

ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

K-Number: K023184 · 2002-11-18

ApplicantBayer Diagnostics Corp.
Decision Date2002-11-18
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Diagnostics Corp.. It received FDA 510(k) clearance on 2002-11-18 under 510(k) number K023184. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM?

ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-11-18. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K023184.

When did ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM receive FDA 510(k) clearance?

ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM received FDA 510(k) clearance on 2002-11-18, under 510(k) number K023184.

Who is the listed applicant for ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM?

The FDA 510(k) record lists Bayer Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM?

The FDA product code for ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM is DIC.

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Other records listing Bayer Diagnostics Corp. 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.

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Related Devices (Code: DIC)

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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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