FDA 510(k)

MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

K-Number: K041133 · 2004-07-02

Decision Date2004-07-02

Product CodeCDD

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER 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 2004-07-02 under 510(k) number K041133. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER?

MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER is a medical device that received FDA 510(k) clearance on 2004-07-02. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K041133.

When did MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER receive FDA 510(k) clearance?

MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER received FDA 510(k) clearance on 2004-07-02, under 510(k) number K041133.

Who is the listed applicant for MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER?

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 MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER?

The FDA product code for MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER is CDD.

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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.