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FDA 510(k)

AU5800(R) CHEMISTRY ANALYZER

K-Number: K112412 · 2011-12-23

ApplicantBeckman Coulter, Inc.
Decision Date2011-12-23
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AU5800(R) CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2011-12-23 under 510(k) number K112412. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AU5800(R) CHEMISTRY ANALYZER?

AU5800(R) CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 2011-12-23. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K112412.

When did AU5800(R) CHEMISTRY ANALYZER receive FDA 510(k) clearance?

AU5800(R) CHEMISTRY ANALYZER received FDA 510(k) clearance on 2011-12-23, under 510(k) number K112412.

Who is the listed applicant for AU5800(R) CHEMISTRY ANALYZER?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AU5800(R) CHEMISTRY ANALYZER?

The FDA product code for AU5800(R) CHEMISTRY ANALYZER is CEM.

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Related Devices (Code: CEM)

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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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