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FDA 510(k)

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II

K-Number: K153644 · 2016-09-07

ApplicantElitechgroup
Decision Date2016-09-07
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II is a medical device manufactured by Elitechgroup. It received FDA 510(k) clearance on 2016-09-07 under approval number K153644. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II?

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II is a medical device that received FDA 510(k) clearance on 2016-09-07. It is manufactured by Elitechgroup. The 510(k) number is K153644.

When was ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II approved by the FDA?

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II received FDA 510(k) clearance on 2016-09-07, under approval number K153644.

What company makes ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II?

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II is manufactured by Elitechgroup.

What is the FDA product code for ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II?

The FDA product code for ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II is CFR.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07615491 PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials RECRUITING NCT06539936 Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING 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

Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026) PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026)

Other Devices by Elitechgroup

K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

Related Devices (Code: CFR)

K151487Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase MethodDiatron U.S., Inc. K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott Laboratories K191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche Diagnostics K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche Diagnostics K252357Glucose2Abbott Ireland K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche Diagnostics

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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