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FDA 510(k)

ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer

K-Number: K161837 · 2016-12-16

ApplicantBeckman Coulter, Inc.
Decision Date2016-12-16
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical 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 2016-12-16 under 510(k) number K161837. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer?

ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer is a medical device that received FDA 510(k) clearance on 2016-12-16. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K161837.

When did ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer receive FDA 510(k) clearance?

ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer received FDA 510(k) clearance on 2016-12-16, under 510(k) number K161837.

Who is the listed applicant for ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical 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 ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer?

The FDA product code for ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer is JGS.

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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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