FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
K Number: K120625
·
Decision Jul 25, 2012
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
19
Applicant Total
183
Review Days
146
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Basic Information
- Device Name
- ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
- K Number
- K120625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- March 1, 2012
- Decision Date
- July 25, 2012
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MXJ), ordered by most recent decision date.
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SeraQuest Herpes Type 1 Specific IgG
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Theranos Herpes Simplex Virus-1 IgG Assay
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HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
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FDA Class 2
·Microbiology
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