FDA 510(k)

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

Numéro K : K230863 · 2023-07-13

Date de décision2023-07-13

Code produitLSR

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K230863. 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 ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit?

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Zeus Scientific. The 510(k) number is K230863.

When did ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit receive FDA 510(k) clearance?

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit received FDA 510(k) clearance on 2023-07-13, under 510(k) number K230863.

Who is the listed applicant for ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit?

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

What is the FDA product code for ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit?

The FDA product code for ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit is LSR.

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Source officielle

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