FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
N LATEX IGA
K Number: K024038
·
Decision Feb 13, 2003
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
53
Applicant Total
343
Review Days
69
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Basic Information
- Device Name
- N LATEX IGA
- K Number
- K024038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- December 6, 2002
- Decision Date
- February 13, 2003
- Product Code
- CZP
- 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 |
|---|---|---|---|
| CZP | Iga, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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