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.
Clearance details
- Applicant
- Roche Diagnostics GmbH
- Product code
- 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
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