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FDA 510(k)

N Latex FLC kappa assay, N Latex FLC lambda assay

K-Number: K182098 · 2018-11-01

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2018-11-01
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N Latex FLC kappa assay, N Latex FLC lambda assay is a medical device manufactured by Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2018-11-01 under approval number K182098. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N Latex FLC kappa assay, N Latex FLC lambda assay?

N Latex FLC kappa assay, N Latex FLC lambda assay is a medical device that received FDA 510(k) clearance on 2018-11-01. It is manufactured by Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K182098.

When was N Latex FLC kappa assay, N Latex FLC lambda assay approved by the FDA?

N Latex FLC kappa assay, N Latex FLC lambda assay received FDA 510(k) clearance on 2018-11-01, under approval number K182098.

What company makes N Latex FLC kappa assay, N Latex FLC lambda assay?

N Latex FLC kappa assay, N Latex FLC lambda assay is manufactured by Siemens Healthcare Diagnostics Products GmbH.

What is the FDA product code for N Latex FLC kappa assay, N Latex FLC lambda assay?

The FDA product code for N Latex FLC kappa assay, N Latex FLC lambda assay is DFH.

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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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