FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
K Number: K012359
·
Decision Nov 29, 2001
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
33
Applicant Total
264
Review Days
127
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Basic Information
- Device Name
- TINA-QUANT COMPLEMENT C4 TEST SYSTEM
- K Number
- K012359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- July 25, 2001
- Decision Date
- November 29, 2001
- Product Code
- DBI
- 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 |
|---|---|---|---|
| DBI | Complement C4, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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