FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lyme-ID IgG Test; Bio-ID800
K Number: K252627
·
Decision Nov 14, 2025
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
1
Review Days
86
Basic Information
- Device Name
- Lyme-ID IgG Test; Bio-ID800
- K Number
- K252627
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inanovate, Inc.
- Date Received
- August 20, 2025
- Decision Date
- November 14, 2025
- 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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