FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
K Number: K230863
·
Decision Jul 13, 2023
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
109
Applicant Total
3
Review Days
106
Basic Information
- Device Name
- ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
- K Number
- K230863
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ZEUS Scientific
- Date Received
- March 29, 2023
- Decision Date
- July 13, 2023
- 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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