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FDA 510(k)

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

K-Number: K210623 · 2022-11-18

ApplicantSebia
Decision Date2022-11-18
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K210623. 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 2022-11-18. The listed applicant is Sebia. The 510(k) number is K210623.

When did FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 receive FDA 510(k) clearance?

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 received FDA 510(k) clearance on 2022-11-18, under 510(k) number K210623.

Who is the listed applicant for FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2?

The FDA 510(k) record lists Sebia as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Sebia as applicant

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.

K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentK231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2K203184HYDRASHIFT 2/4 isatuximabK192095CAPI 3 Immunotyping, Capillarys 3 TeraK190851HYDRASHIFT 2/4 daratumumabK180762CAPI 3 HEMOGLOBIN(E)

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Related Devices (Code: DFH)

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.K211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.K220001Diazyme 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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