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FDA 510(k)

LOCI Total Vitamin D Total Assay, LOCI VITD CAL

K-Number: K162298 · 2017-03-16

ApplicantSiemens Healthcare Diagnostics
Decision Date2017-03-16
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Siemens Healthcare Diagnostics. The 510(k) number is K162298.

When was LOCI Total Vitamin D Total Assay, LOCI VITD CAL approved by the FDA?

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

What company makes LOCI Total Vitamin D Total Assay, LOCI VITD CAL?

LOCI Total Vitamin D Total Assay, LOCI VITD CAL is manufactured by Siemens Healthcare Diagnostics.

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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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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