FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sofia 2 Lyme FIA, Sofia Lyme Control Set
K Number: K173496
·
Decision Aug 30, 2018
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
37
Review Days
290
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Basic Information
- Device Name
- Sofia 2 Lyme FIA, Sofia Lyme Control Set
- K Number
- K173496
- Device Class
- FDA class 2
- Clearance Type
- Dual Track
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quidel Corporation
- Date Received
- November 13, 2017
- Decision Date
- August 30, 2018
- Product Code
- LSR
- 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 |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | FDA class 2 | Microbiology |
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