FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Elecsys Syphilis
K Number: K211302
·
Decision Jul 20, 2021
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
34
Applicant Total
183
Review Days
82
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Basic Information
- Device Name
- Elecsys Syphilis
- K Number
- K211302
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- April 29, 2021
- Decision Date
- July 20, 2021
- Product Code
- LIP
- 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 |
|---|---|---|---|
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | FDA class 2 | Microbiology |
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