FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
LAMBDA LIGHT CHAINS
K Number: K083601
·
Decision Jun 22, 2009
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
52
Applicant Total
12
Review Days
199
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Basic Information
- Device Name
- LAMBDA LIGHT CHAINS
- K Number
- K083601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SENTINEL CH. SpA
- Date Received
- December 5, 2008
- Decision Date
- June 22, 2009
- Product Code
- DEH
- 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 |
|---|---|---|---|
| DEH | Lambda, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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