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FDA 510(k)

Anti-Borrelia burgdorferi US Westernblot (IgG)

K-Number: K161513 · 2016-08-25

ApplicantEuroimmun US
Decision Date2016-08-25
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Anti-Borrelia burgdorferi US Westernblot (IgG) is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun US. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K161513. 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 Anti-Borrelia burgdorferi US Westernblot (IgG)?

Anti-Borrelia burgdorferi US Westernblot (IgG) is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Euroimmun US. The 510(k) number is K161513.

When did Anti-Borrelia burgdorferi US Westernblot (IgG) receive FDA 510(k) clearance?

Anti-Borrelia burgdorferi US Westernblot (IgG) received FDA 510(k) clearance on 2016-08-25, under 510(k) number K161513.

Who is the listed applicant for Anti-Borrelia burgdorferi US Westernblot (IgG)?

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

What is the FDA product code for Anti-Borrelia burgdorferi US Westernblot (IgG)?

The FDA product code for Anti-Borrelia burgdorferi US Westernblot (IgG) is LSR.

Other records listing Euroimmun US 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.

K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternK172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternK172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternK172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

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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

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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