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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 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 2019-05-03 under 510(k) 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. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K190879.

When did N Latex FLC kappa, N Latex FLC lambda receive FDA 510(k) clearance?

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

Who is the listed applicant for N Latex FLC kappa, N Latex FLC lambda?

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, N Latex FLC lambda?

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

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayDiazyme Laboratories, Inc.K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2SebiaK231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2SebiaK211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.

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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