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FDA 510(k)

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE

K-Number: K042015 · 2004-09-29

ApplicantBayer Healthcare, Diagnostics Division
Decision Date2004-09-29
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, Diagnostics Division. It received FDA 510(k) clearance on 2004-09-29 under 510(k) number K042015. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE?

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE is a medical device that received FDA 510(k) clearance on 2004-09-29. The listed applicant is Bayer Healthcare, Diagnostics Division. The 510(k) number is K042015.

When did ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE receive FDA 510(k) clearance?

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE received FDA 510(k) clearance on 2004-09-29, under 510(k) number K042015.

Who is the listed applicant for ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE?

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

What is the FDA product code for ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE?

The FDA product code for ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE is CGA.

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Other records listing Bayer Healthcare, Diagnostics Division 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.

K033643CO2 CALIBRATOR/DILUENT

Related Devices (Code: CGA)

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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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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