FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Theranos Herpes Simplex Virus-1 IgG Assay
K Number: K143236
·
Decision Jul 2, 2015
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
19
Applicant Total
1
Review Days
232
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Basic Information
- Device Name
- Theranos Herpes Simplex Virus-1 IgG Assay
- K Number
- K143236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theranos, Inc.
- Date Received
- November 12, 2014
- Decision Date
- July 2, 2015
- 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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