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FDA 510(k)

N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2

K-Number: K171742 · 2017-11-17

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2017-11-17
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K171742. 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 FLC Standard SL, N FLC Control SL1 & SL2?

N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K171742.

When did N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 receive FDA 510(k) clearance?

N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 received FDA 510(k) clearance on 2017-11-17, under 510(k) number K171742.

Who is the listed applicant for N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2?

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

What is the FDA product code for N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2?

The FDA product code for N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 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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