FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
K Number: K040434
·
Decision Mar 10, 2004
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
75
Applicant Total
264
Review Days
20
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Basic Information
- Device Name
- ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
- K Number
- K040434
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- February 19, 2004
- Decision Date
- March 10, 2004
- Product Code
- DEW
- 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 |
|---|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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