FDA 510(k)

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

Numéro K : K200023 · 2020-04-06

Date de décision2020-04-06

Code produitLSR

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

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 2020-04-06 under 510(k) number K200023. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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 2020-04-06. The listed applicant is Gold Standard Diagnostics. The 510(k) number is K200023.

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 2020-04-06, under 510(k) number K200023.

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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Autres dossiers indiquant Gold Standard Diagnostics en tant que demandeur

K203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit K203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit K200025Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit K180264Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

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Source officielle

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