FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
K Number: K131334
·
Decision Feb 28, 2014
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
19
Applicant Total
14
Review Days
295
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Basic Information
- Device Name
- HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
- K Number
- K131334
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gold Standard Diagnostics
- Date Received
- May 9, 2013
- Decision Date
- February 28, 2014
- Product Code
- MXJ
- 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 |
|---|---|---|---|
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | FDA class 2 | Microbiology |
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