FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Cystatin C
K Number: K242585
·
Decision May 16, 2025
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
21
Applicant Total
12
Review Days
259
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Basic Information
- Device Name
- Cystatin C
- K Number
- K242585
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SENTINEL CH. SpA
- Date Received
- August 30, 2024
- Decision Date
- May 16, 2025
- Product Code
- NDY
- 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 |
|---|---|---|---|
| NDY | Test, Cystatin C | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NDY), ordered by most recent decision date.
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COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
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