FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
K Number: K020823
·
Decision May 14, 2002
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
8
Applicant Total
1
Review Days
61
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Basic Information
- Device Name
- PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
- K Number
- K020823
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sanquin Blood Supply Foundation
- Date Received
- March 14, 2002
- Decision Date
- May 14, 2002
- Product Code
- DFZ
- 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 |
|---|---|---|---|
| DFZ | Igg (Gamma Chain Specific), Antigen, Antiserum, Control | FDA class 2 | Immunology |
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