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 a medical device manufactured by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2023-07-20 under approval 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. It is manufactured by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. The 510(k) number is K220977.

When was ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer approved by the FDA?

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

What company makes ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer?

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer is manufactured by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd..

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.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06888687 Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes. ACTIVE_NOT_RECRUITING NCT07612085 A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41760572 Trends in use of continuous glucose monitors among individuals with type 2 diabetes enrolled in Medicare Advantage (2021-2023). Journal of managed care & specialty pharmacy (2026)

Other Devices by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.

K221114Immunoglobulin G (IgG)

Related Devices (Code: JGS)

K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerBeckman Coulter, Inc. K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit EvaluatorInstrumentation Laboratory CO K153357i-STAT Alinity System with i-STAT Sodium testAbbott Point of Care, Inc. K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)Siemens Healthcare Diagnostics K180428Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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.