FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
N ANTISERA TO HUMAN CERULOPLASMIN
K Number: K053074
·
Decision Mar 16, 2006
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
18
Applicant Total
343
Review Days
135
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Basic Information
- Device Name
- N ANTISERA TO HUMAN CERULOPLASMIN
- K Number
- K053074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5210
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- November 1, 2005
- Decision Date
- March 16, 2006
- Product Code
- DDB
- 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 |
|---|---|---|---|
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DDB), ordered by most recent decision date.
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FDA 510(k)
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IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
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CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT
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QM300 CERULOPLASMIN ANTIBODY PACK
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NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
FDA 510(k)
FDA Class 2
·Immunology
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