FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
K Number: K141143
·
Decision Jul 17, 2014
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
21
Applicant Total
183
Review Days
76
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Basic Information
- Device Name
- COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
- K Number
- K141143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- May 2, 2014
- Decision Date
- July 17, 2014
- 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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DIAZYME CYSTATIN C POC TEST KIT
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K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
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