FDA 510(k)

Anticorps anti-anticorps cytoplasmiques neutrophiles (fixés à l'éthanol); Anticorps anti-anticorps cytoplasmiques neutrophiles (fixés au formol)

Numéro K : K243776 · 2025-05-07

Date de décision2025-05-07

Code produitMOB

Comité consultatifIM

DécisionSubstantially Equivalent

Résumé du dispositif

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific. It received FDA 510(k) clearance on 2025-05-07 under 510(k) number K243776. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)?

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) is a medical device that received FDA 510(k) clearance on 2025-05-07. The listed applicant is Zeus Scientific. The 510(k) number is K243776.

When did Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) receive FDA 510(k) clearance?

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) received FDA 510(k) clearance on 2025-05-07, under 510(k) number K243776.

Who is the listed applicant for Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)?

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 Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)?

The FDA product code for Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) is MOB.

Essais cliniques associés

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Autres dossiers indiquant Zeus Scientific en tant que demandeur

K261466Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM K250814Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB K250666Alegria Flash CTD Screen K250408Alegria Flash ENA Screen K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFine K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

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Dispositifs connexes (Code : MOB)

K261466Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMZeus Scientific K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES ANCA Éthanol, AESKUSLIDES ANCA FormolAesku.Diagnostics GmbH & Co. KG K173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia AB K161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova Diagnostics, Inc.

Source officielle

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