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FDA 510(k)

Lyme-ID IgG Test; Bio-ID800

K-Number: K252627 · 2025-11-14

ApplicantInanovate, Inc.
Decision Date2025-11-14
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Lyme-ID IgG Test; Bio-ID800 is a medical device manufactured by Inanovate, Inc.. It received FDA 510(k) clearance on 2025-11-14 under approval number K252627. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lyme-ID IgG Test; Bio-ID800?

Lyme-ID IgG Test; Bio-ID800 is a medical device that received FDA 510(k) clearance on 2025-11-14. It is manufactured by Inanovate, Inc.. The 510(k) number is K252627.

When was Lyme-ID IgG Test; Bio-ID800 approved by the FDA?

Lyme-ID IgG Test; Bio-ID800 received FDA 510(k) clearance on 2025-11-14, under approval number K252627.

What company makes Lyme-ID IgG Test; Bio-ID800?

Lyme-ID IgG Test; Bio-ID800 is manufactured by Inanovate, Inc..

What is the FDA product code for Lyme-ID IgG Test; Bio-ID800?

The FDA product code for Lyme-ID IgG Test; Bio-ID800 is LSR.

Related Devices (Code: LSR)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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