FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS
K Number: K961784
·
Decision Oct 31, 1996
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
3
Review Days
182
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Basic Information
- Device Name
- COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS
- K Number
- K961784
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sienna Biotech, Inc.
- Date Received
- May 2, 1996
- Decision Date
- October 31, 1996
- Product Code
- LQN
- 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 |
|---|---|---|---|
| LQN | Latex Agglutination Assay, Rubella | FDA class 2 | Microbiology |
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