Elecsys Calcitonin— 510(k) K252431
Substantially EquivalentRoche Diagnostics GmbH
FDA 510(k) clearance K252431 for Elecsys Calcitonin, Substantially Equivalent on 2026-04-24. Applicant: Roche Diagnostics GmbH. Device class: 2.
Summary
Roche Diagnostics' Elecsys Calcitonin is filed under product code JKR (Radioimmunoassay, Calcitonin). The record doesn't describe the assay beyond its name and that code name.
Class II, 21 CFR 862.1140. It came in as a Traditional 510(k), and Clinical Chemistry is both the classification panel and the review panel.
Roche Diagnostics filed from Mannheim, Germany. Review took 266 calendar days (August 1, 2025 to April 24, 2026).
Clearance details
- Applicant
- Roche Diagnostics GmbH
- Product code
- Product code JKR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1140
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mannheim, DE
Recent devices under product code JKR
view all- K182012 — ADVIA Centaur Calcitonin (CALCT) assay
- K132828 — ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
- K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
- K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
- K990073 — CALCITONIN
More clearances from Roche Diagnostics GmbH
view allData sourced from openFDA. This site is unofficial and independent of the FDA.