FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COPALIS CMV TOTAL ANTIBODY ASSAY
K Number: K955799
·
Decision Jul 10, 1996
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
11
Applicant Total
3
Review Days
201
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Basic Information
- Device Name
- COPALIS CMV TOTAL ANTIBODY ASSAY
- K Number
- K955799
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sienna Biotech, Inc.
- Date Received
- December 22, 1995
- Decision Date
- July 10, 1996
- Product Code
- LJO
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LJO | Antigen, Iha, Cytomegalovirus | FDA class 2 | Microbiology |
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