FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAZYME CYSTATIN C ASSAY
K Number: K093680
·
Decision Apr 8, 2010
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
21
Applicant Total
41
Review Days
132
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Basic Information
- Device Name
- DIAZYME CYSTATIN C ASSAY
- K Number
- K093680
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diazyme Laboratories
- Date Received
- November 27, 2009
- Decision Date
- April 8, 2010
- 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 |
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