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FDA 510(k)

cobas pulse blood glucose monitoring system

K-Number: K252323 · 2026-06-12

ApplicantRoche Diagnostics
Decision Date2026-06-12
Product CodePZI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

cobas pulse blood glucose monitoring system is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K252323. The device is classified under product code PZI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas pulse blood glucose monitoring system?

cobas pulse blood glucose monitoring system is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Roche Diagnostics. The 510(k) number is K252323.

When did cobas pulse blood glucose monitoring system receive FDA 510(k) clearance?

cobas pulse blood glucose monitoring system received FDA 510(k) clearance on 2026-06-12, under 510(k) number K252323.

Who is the listed applicant for cobas pulse blood glucose monitoring system?

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 cobas pulse blood glucose monitoring system?

The FDA product code for cobas pulse blood glucose monitoring system is PZI.

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Related Devices (Code: PZI)

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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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