FDA 510(k)

LOCI Total Vitamin D Total Assay, LOCI VITD CAL

Número K: K162298 · 2017-03-16

RequerenteSiemens Healthcare Diagnostics

Data da decisão2017-03-16

Código do produtoMRG

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Fonte oficial

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