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FDA 510(k)

DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent

K-Number: K162208 · 2017-01-09

ApplicantBeckman Coulter, Inc.
Decision Date2017-01-09
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent 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 2017-01-09 under 510(k) number K162208. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent?

DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent is a medical device that received FDA 510(k) clearance on 2017-01-09. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K162208.

When did DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent receive FDA 510(k) clearance?

DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent received FDA 510(k) clearance on 2017-01-09, under 510(k) number K162208.

Who is the listed applicant for DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent?

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 DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent?

The FDA product code for DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent is CFN.

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Related Devices (Code: CFN)

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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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