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FDA 510(k)

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

K-Number: K203295 · 2021-03-22

ApplicantGold Standard Diagnostics
Decision Date2021-03-22
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit 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 2021-03-22 under 510(k) number K203295. 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 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit?

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit is a medical device that received FDA 510(k) clearance on 2021-03-22. The listed applicant is Gold Standard Diagnostics. The 510(k) number is K203295.

When did Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit receive FDA 510(k) clearance?

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit received FDA 510(k) clearance on 2021-03-22, under 510(k) number K203295.

Who is the listed applicant for Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit?

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 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit?

The FDA product code for Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit is LSR.

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Other records listing Gold Standard Diagnostics 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.

K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemK203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitK203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitK203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/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.

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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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