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FDA 510(k)

Glucose2

K-Number: K252357 · 2025-10-24

ApplicantAbbott Ireland
Decision Date2025-10-24
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Glucose2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland. It received FDA 510(k) clearance on 2025-10-24 under 510(k) 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. The listed applicant is Abbott Ireland. The 510(k) number is K252357.

When did Glucose2 receive FDA 510(k) clearance?

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

Who is the listed applicant for Glucose2?

The FDA 510(k) record lists Abbott Ireland as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Glucose2?

The FDA product code for Glucose2 is CFR.

Other records listing Abbott Ireland 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.

K244042Calcium2

Related Devices (Code: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroupK151487Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase MethodDiatron U.S., Inc.

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.

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