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FDA 510(k)

Borrelia B31 ViraChip IgG Test Kit

K-Number: K163504 · 2017-07-12

ApplicantViramed Biotech AG
Decision Date2017-07-12
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Borrelia B31 ViraChip IgG Test Kit is the device name listed in this FDA 510(k) record. The listed applicant is Viramed Biotech AG. It received FDA 510(k) clearance on 2017-07-12 under 510(k) number K163504. 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 Borrelia B31 ViraChip IgG Test Kit?

Borrelia B31 ViraChip IgG Test Kit is a medical device that received FDA 510(k) clearance on 2017-07-12. The listed applicant is Viramed Biotech AG. The 510(k) number is K163504.

When did Borrelia B31 ViraChip IgG Test Kit receive FDA 510(k) clearance?

Borrelia B31 ViraChip IgG Test Kit received FDA 510(k) clearance on 2017-07-12, under 510(k) number K163504.

Who is the listed applicant for Borrelia B31 ViraChip IgG Test Kit?

The FDA 510(k) record lists Viramed Biotech AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Borrelia B31 ViraChip IgG Test Kit?

The FDA product code for Borrelia B31 ViraChip IgG Test Kit is LSR.

Other records listing Viramed Biotech AG as applicant

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.

K220016Viramed Borrela All-In-One ViraChip Test KitK163695Borrelia B31 ViraChip IgM Test Kit

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)K252627Lyme-ID IgG Test; Bio-ID800Inanovate, Inc.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 AG

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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