FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT
K Number: K944876
·
Decision Dec 15, 1994
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
7
Applicant Total
3
Review Days
73
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Basic Information
- Device Name
- HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT
- K Number
- K944876
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5530
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Research Diagnostics, Inc.
- Date Received
- October 3, 1994
- Decision Date
- December 15, 1994
- Product Code
- DAS
- 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 |
|---|---|---|---|
| DAS | Igg (Fc Fragment Specific), Antigen, Antiserum, Control | FDA class 1 | Immunology |
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