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FDA 510(k)

Elecsys Calcitonin

K-Number: K252431 · 2026-04-24

ApplicantRoche Diagnostics GmbH
Decision Date2026-04-24
Product CodeJKR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys Calcitonin is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics GmbH. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K252431. The device is classified under product code JKR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys Calcitonin?

Elecsys Calcitonin is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Roche Diagnostics GmbH. The 510(k) number is K252431.

When did Elecsys Calcitonin receive FDA 510(k) clearance?

Elecsys Calcitonin received FDA 510(k) clearance on 2026-04-24, under 510(k) number K252431.

Who is the listed applicant for Elecsys Calcitonin?

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

What is the FDA product code for Elecsys Calcitonin?

The FDA product code for Elecsys Calcitonin is JKR.

Other records listing Roche Diagnostics GmbH as applicant

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Related Devices (Code: JKR)

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.

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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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