FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Elecsys Calcitonin
K Number: K252431
·
Decision Apr 24, 2026
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
19
Applicant Total
5
Review Days
266
Basic Information
- Device Name
- Elecsys Calcitonin
- K Number
- K252431
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1140
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics GmbH
- Date Received
- August 1, 2025
- Decision Date
- April 24, 2026
- Product Code
- JKR
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JKR | Radioimmunoassay, Calcitonin | FDA class 2 | Clinical Chemistry |
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Other Clearances by Roche Diagnostics GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K143446 | Accu-Chek FlexLink Plus infusion set | Aug 13, 2015 | Substantially Equivalent |
| K981282 | ELECSYS AFP | May 1, 1998 | Substantially Equivalent |
| K981281 | ELECSYS CALCHECK FERRITIN | Apr 24, 1998 | Substantially Equivalent |
| K981278 | ELECSYS CALCHECK CA 125II | Apr 23, 1998 | Substantially Equivalent |