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FDA 510(k)

KAPPA LIGHT CHAINS

K-Number: K083602 · 2009-09-03

ApplicantSENTINEL CH. SpA
Decision Date2009-09-03
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KAPPA LIGHT CHAINS is the device name listed in this FDA 510(k) record. The listed applicant is SENTINEL CH. SpA. It received FDA 510(k) clearance on 2009-09-03 under 510(k) number K083602. 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 KAPPA LIGHT CHAINS?

KAPPA LIGHT CHAINS is a medical device that received FDA 510(k) clearance on 2009-09-03. The listed applicant is SENTINEL CH. SpA. The 510(k) number is K083602.

When did KAPPA LIGHT CHAINS receive FDA 510(k) clearance?

KAPPA LIGHT CHAINS received FDA 510(k) clearance on 2009-09-03, under 510(k) number K083602.

Who is the listed applicant for KAPPA LIGHT CHAINS?

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

What is the FDA product code for KAPPA LIGHT CHAINS?

The FDA product code for KAPPA LIGHT CHAINS is DFH.

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Other records listing SENTINEL CH. SpA as applicant

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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.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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