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 a medical device manufactured by Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2017-11-17 under approval 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. It is manufactured by Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K171742.

When was N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 approved by the FDA?

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 approval number K171742.

What company makes 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 manufactured by Siemens Healthcare Diagnostics Products GmbH.

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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Related Devices (Code: DFH)

K153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain CalibratorDiazyme Laboratories K182098N Latex FLC kappa assay, N Latex FLC lambda assaySiemens Healthcare Diagnostics Products GmbH K173732Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitThe Binding Site Group , Ltd. K181438Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc. K190879N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH K201496N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH

Official Source

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