FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
K Number: K112343
·
Decision Jan 20, 2012
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
34
Applicant Total
152
Review Days
158
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Basic Information
- Device Name
- TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
- K Number
- K112343
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date Received
- August 15, 2011
- Decision Date
- January 20, 2012
- 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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