FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
K Number: K131441
·
Decision Aug 9, 2013
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
71
Review Days
81
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Basic Information
- Device Name
- LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
- K Number
- K131441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DiaSorin, Inc.
- Date Received
- May 20, 2013
- Decision Date
- August 9, 2013
- Product Code
- LGD
- 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 |
|---|---|---|---|
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | FDA class 2 | Microbiology |
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