FDA 510(k)

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay

N.º K: K253358 · 2025-12-19

Fecha de decisión2025-12-19

Código de productoDFH

Comité asesorIM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K253358. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay?

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Diazyme Laboratories, Inc.. The 510(k) number is K253358.

When did Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay receive FDA 510(k) clearance?

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay received FDA 510(k) clearance on 2025-12-19, under 510(k) number K253358.

Who is the listed applicant for Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay?

The FDA 510(k) record lists Diazyme Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay?

The FDA product code for Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay is DFH.

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Otros registros que enlistan a Diazyme Laboratories, Inc. como solicitante

K253069Lipoprotein (a) Molarity Assay K252336Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay K243462Diazyme Colorimetric Lithium Assay K211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay K220001Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

Ver todos los 11 dispositivos →

Dispositivos relacionados (Código: DFH)

K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2Sebia K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2Sebia K211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.K220001Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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