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FDA 510(k)

N Latex FLC kappa, N Latex FLC lambda

K-Number: K190879 · 2019-05-03

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2019-05-03
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N Latex FLC kappa, N Latex FLC lambda is a medical device manufactured by Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2019-05-03 under approval number K190879. 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, N Latex FLC lambda?

N Latex FLC kappa, N Latex FLC lambda is a medical device that received FDA 510(k) clearance on 2019-05-03. It is manufactured by Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K190879.

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

N Latex FLC kappa, N Latex FLC lambda received FDA 510(k) clearance on 2019-05-03, under approval number K190879.

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

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

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

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

Other Devices by Siemens Healthcare Diagnostics Products GmbH

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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 K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2Siemens Healthcare Diagnostics Products GmbH 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. K201496N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH

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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