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 a medical device manufactured by Roche Diagnostics GmbH. It received FDA 510(k) clearance on 2026-04-24 under approval 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. It is manufactured by Roche Diagnostics GmbH. The 510(k) number is K252431.
When was Elecsys Calcitonin approved by the FDA?
Elecsys Calcitonin received FDA 510(k) clearance on 2026-04-24, under approval number K252431.
What company makes Elecsys Calcitonin?
Elecsys Calcitonin is manufactured by Roche Diagnostics GmbH.
What is the FDA product code for Elecsys Calcitonin?
The FDA product code for Elecsys Calcitonin is JKR.
Related Devices (Code: JKR)
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.