FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
K Number: K013263
·
Decision Jul 29, 2002
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
27
Applicant Total
1
Review Days
301
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Basic Information
- Device Name
- FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
- K Number
- K013263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fred Hutchinson Cancer Research Center
- Date Received
- October 1, 2001
- Decision Date
- July 29, 2002
- Product Code
- LKP
- 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 |
|---|---|---|---|
| LKP | Anti-Sm Antibody, Antigen And Control | FDA class 2 | Immunology |
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