FDA 510(k)

Glucose2

K-Number: K252357 · 2025-10-24

Decision Date2025-10-24

Product CodeCFR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Glucose2 is a medical device manufactured by Abbott Ireland. It received FDA 510(k) clearance on 2025-10-24 under approval number K252357. 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 Glucose2?

Glucose2 is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Abbott Ireland. The 510(k) number is K252357.

When was Glucose2 approved by the FDA?

Glucose2 received FDA 510(k) clearance on 2025-10-24, under approval number K252357.

What company makes Glucose2?

Glucose2 is manufactured by Abbott Ireland.

What is the FDA product code for Glucose2?

The FDA product code for Glucose2 is CFR.

Other Devices by Abbott Ireland

K244042Calcium2

Related Devices (Code: CFR)

K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup 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 K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.