FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TINA-QUANT TRANSFERRIN VER.2
K Number: K012371
·
Decision Sep 19, 2001
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
47
Applicant Total
264
Review Days
55
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Basic Information
- Device Name
- TINA-QUANT TRANSFERRIN VER.2
- K Number
- K012371
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5880
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- July 26, 2001
- Decision Date
- September 19, 2001
- Product Code
- DDG
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DDG | Transferrin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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