FDA 510(k)

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions

K-Number: K253490 · 2026-02-12

Decision Date2026-02-12

Product CodeCFR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2026-02-12 under approval number K253490. 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 Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions?

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions is a medical device that received FDA 510(k) clearance on 2026-02-12. It is manufactured by Roche Diagnostics. The 510(k) number is K253490.

When was Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions approved by the FDA?

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions received FDA 510(k) clearance on 2026-02-12, under approval number K253490.

What company makes Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions?

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions is manufactured by Roche Diagnostics.

What is the FDA product code for Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions?

The FDA product code for Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions is CFR.

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Related PubMed Literature

PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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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 K252357Glucose2Abbott Ireland

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.