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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 the device name listed in this FDA 510(k) record. The listed applicant is Inanovate, Inc.. It received FDA 510(k) clearance on 2025-11-14 under 510(k) 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. The listed applicant is Inanovate, Inc.. The 510(k) number is K252627.

When did Lyme-ID IgG Test; Bio-ID800 receive FDA 510(k) clearance?

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

Who is the listed applicant for Lyme-ID IgG Test; Bio-ID800?

The FDA 510(k) record lists Inanovate, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.K233367iDart Lyme IgG ImmunoBlot KitId-Fish Technology, Inc.K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitZeus ScientificK220016Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AGK203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard Diagnostics

Official Source

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

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