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FDA 510(k)

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

K-Number: K253490 · 2026-02-12

ApplicantRoche Diagnostics
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 the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2026-02-12 under 510(k) 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. The listed applicant is Roche Diagnostics. The 510(k) number is K253490.

When did Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions receive FDA 510(k) clearance?

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

Who is the listed applicant for Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions?

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

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 Devices (Code: CFR)

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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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