FDA 510(k)

LOCI Total Vitamin D Total Assay, LOCI VITD CAL

N.º K: K162298 · 2017-03-16

SolicitanteSiemens Healthcare Diagnostics

Fecha de decisión2017-03-16

Código de productoMRG

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

LOCI Total Vitamin D Total Assay, LOCI VITD CAL is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2017-03-16 under 510(k) number K162298. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LOCI Total Vitamin D Total Assay, LOCI VITD CAL?

LOCI Total Vitamin D Total Assay, LOCI VITD CAL is a medical device that received FDA 510(k) clearance on 2017-03-16. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K162298.

When did LOCI Total Vitamin D Total Assay, LOCI VITD CAL receive FDA 510(k) clearance?

LOCI Total Vitamin D Total Assay, LOCI VITD CAL received FDA 510(k) clearance on 2017-03-16, under 510(k) number K162298.

Who is the listed applicant for LOCI Total Vitamin D Total Assay, LOCI VITD CAL?

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

What is the FDA product code for LOCI Total Vitamin D Total Assay, LOCI VITD CAL?

The FDA product code for LOCI Total Vitamin D Total Assay, LOCI VITD CAL is MRG.

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Otros registros que enlistan a Siemens Healthcare Diagnostics como solicitante

K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)K162977ADVIA 2120i, ADVIA 2120 K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)K162538ADVIA Centaur Insulina (IRI) Material de Curva Maestra (MCM), ADVIA Centaur (IRI) Calibrador K151964Xprecia Stride Coagulation System, Xprecia System PT Controls

Dispositivos relacionados (Código: MRG)

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.K221817ALFIS VITAMINA D, ANALIZADOR ALFIS-3Immunostics Inc.,K223503Access 25(OH) Vitamina D TotalBeckman Coulter, Inc.K210901Elecsys Vitamin D total IIIRoche Diagnostics K200509ADVIA Centaur Vitamina D Total (VitD)Siemens Healthcare Diagnostics, Inc.K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.

Fuente oficial

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