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FDA 510(k)

ADVIA IMS GLUCOSE ASSAY

K-Number: K052163 · 2005-10-11

ApplicantBayer Healthcare, LLC
Decision Date2005-10-11
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA IMS GLUCOSE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2005-10-11 under 510(k) number K052163. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA IMS GLUCOSE ASSAY?

ADVIA IMS GLUCOSE ASSAY is a medical device that received FDA 510(k) clearance on 2005-10-11. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K052163.

When did ADVIA IMS GLUCOSE ASSAY receive FDA 510(k) clearance?

ADVIA IMS GLUCOSE ASSAY received FDA 510(k) clearance on 2005-10-11, under 510(k) number K052163.

Who is the listed applicant for ADVIA IMS GLUCOSE ASSAY?

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

What is the FDA product code for ADVIA IMS GLUCOSE ASSAY?

The FDA product code for ADVIA IMS GLUCOSE ASSAY is CFR.

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Related Devices (Code: CFR)

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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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