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FDA 510(k)

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer

K-Number: K220977 · 2023-07-20

ApplicantBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Decision Date2023-07-20
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2023-07-20 under 510(k) number K220977. 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 Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer?

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer is a medical device that received FDA 510(k) clearance on 2023-07-20. The listed applicant is Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. The 510(k) number is K220977.

When did ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer receive FDA 510(k) clearance?

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer received FDA 510(k) clearance on 2023-07-20, under 510(k) number K220977.

Who is the listed applicant for ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer?

The FDA 510(k) record lists Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer?

The FDA product code for ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer is JGS.

Other records listing Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221114Immunoglobulin G (IgG)

Related Devices (Code: JGS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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