Lyme-ID IgG Test; Bio-ID800— 510(k) K252627
Substantially EquivalentInanovate, Inc.
FDA 510(k) clearance K252627 for Lyme-ID IgG Test; Bio-ID800, Substantially Equivalent on 2025-11-14. Applicant: Inanovate, Inc.. Device class: 2.
Clearance details
- Applicant
- Inanovate, Inc.
- Product code
- Code LSR
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sioux Falls, SD, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.