FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SELISA ANTI-N DNA ANTIBODIES
K Number: K940585
·
Decision Jun 10, 1994
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
28
Applicant Total
4
Review Days
122
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Basic Information
- Device Name
- SELISA ANTI-N DNA ANTIBODIES
- K Number
- K940585
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cambridge Life Sciences Plc.
- Date Received
- February 8, 1994
- Decision Date
- June 10, 1994
- Product Code
- LRM
- 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 |
|---|---|---|---|
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | FDA class 2 | Immunology |
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