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FDA 510(k)

BORRELIA BURGDORFERI IGM BLOT TEST

K-Number: K113846 · 2012-06-01

ApplicantGold Standard Diagnostics
Decision Date2012-06-01
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BORRELIA BURGDORFERI IGM BLOT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gold Standard Diagnostics. It received FDA 510(k) clearance on 2012-06-01 under 510(k) number K113846. 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 BURGDORFERI IGM BLOT TEST?

BORRELIA BURGDORFERI IGM BLOT TEST is a medical device that received FDA 510(k) clearance on 2012-06-01. The listed applicant is Gold Standard Diagnostics. The 510(k) number is K113846.

When did BORRELIA BURGDORFERI IGM BLOT TEST receive FDA 510(k) clearance?

BORRELIA BURGDORFERI IGM BLOT TEST received FDA 510(k) clearance on 2012-06-01, under 510(k) number K113846.

Who is the listed applicant for BORRELIA BURGDORFERI IGM BLOT TEST?

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

What is the FDA product code for BORRELIA BURGDORFERI IGM BLOT TEST?

The FDA product code for BORRELIA BURGDORFERI IGM BLOT TEST is LSR.

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Other records listing Gold Standard Diagnostics as applicant

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K203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitK203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitK203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitK203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitK200025Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitK200023Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

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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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