FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K Number: K032535
·
Decision Sep 10, 2003
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
143
Applicant Total
264
Review Days
23
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Basic Information
- Device Name
- MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
- K Number
- K032535
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- August 18, 2003
- Decision Date
- September 10, 2003
- Product Code
- DHR
- 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 |
|---|---|---|---|
| DHR | System, Test, Rheumatoid Factor | FDA class 2 | Immunology |
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