K252627
- 510(k) number
- K252627
- Device name
- Lyme-ID IgG Test; Bio-ID800
- Applicant
- Inanovate, Inc. SD · US
- Product code
- LSR — Reagent, Borrelia Serological Reagent
- Decision date
- 2025-11-14
- Date received
- 2025-08-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252627.pdf
Official FDA record: K252627
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.