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FDA 510(k)

TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM

K-Number: K053020 · 2005-12-30

ApplicantBayer Healthcare, LLC
Decision Date2005-12-30
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM 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 2005-12-30 under 510(k) number K053020. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM?

TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-30. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K053020.

When did TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM receive FDA 510(k) clearance?

TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM received FDA 510(k) clearance on 2005-12-30, under 510(k) number K053020.

Who is the listed applicant for TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM?

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 TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM?

The FDA product code for TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM is MMI.

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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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