510(k) K252627— Lyme-ID IgG Test; Bio-ID800

Substantially Equivalent

Inanovate, Inc.

Clearance details

Applicant: Inanovate, Inc.
Product code: Code LSR
Advisory panel: Microbiology
Date received: 2025-08-20
Decision date: 2025-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sioux Falls, SD, US

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