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FDA 510(k)

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2

K-Number: K231601 · 2024-02-23

ApplicantSebia
Decision Date2024-02-23
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 is a medical device manufactured by Sebia. It received FDA 510(k) clearance on 2024-02-23 under approval number K231601. 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 FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2?

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 is a medical device that received FDA 510(k) clearance on 2024-02-23. It is manufactured by Sebia. The 510(k) number is K231601.

When was FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 approved by the FDA?

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 received FDA 510(k) clearance on 2024-02-23, under approval number K231601.

What company makes FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2?

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 is manufactured by Sebia.

What is the FDA product code for FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2?

The FDA product code for FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 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 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. K190879N 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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