FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
K Number: K081687
·
Decision Nov 10, 2008
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
9
Applicant Total
43
Review Days
146
Basic Information
- Device Name
- LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
- K Number
- K081687
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DIASORIN, INC.
- Date Received
- June 17, 2008
- Decision Date
- November 10, 2008
- Product Code
- MYF
- 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 |
|---|---|---|---|
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | FDA class 2 | Microbiology |
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