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FDA 510(k)

FREELITE HUMAN KAPPA AND LAMBDA KITS

K-Number: K040009 · 2004-03-11

ApplicantThe Binding Site, Ltd.
Decision Date2004-03-11
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FREELITE HUMAN KAPPA AND LAMBDA KITS is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site, Ltd.. It received FDA 510(k) clearance on 2004-03-11 under 510(k) number K040009. 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 FREELITE HUMAN KAPPA AND LAMBDA KITS?

FREELITE HUMAN KAPPA AND LAMBDA KITS is a medical device that received FDA 510(k) clearance on 2004-03-11. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K040009.

When did FREELITE HUMAN KAPPA AND LAMBDA KITS receive FDA 510(k) clearance?

FREELITE HUMAN KAPPA AND LAMBDA KITS received FDA 510(k) clearance on 2004-03-11, under 510(k) number K040009.

Who is the listed applicant for FREELITE HUMAN KAPPA AND LAMBDA KITS?

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

What is the FDA product code for FREELITE HUMAN KAPPA AND LAMBDA KITS?

The FDA product code for FREELITE HUMAN KAPPA AND LAMBDA KITS is DFH.

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Other records listing The Binding Site, Ltd. 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.

K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitK090920HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)K083289HUMAN BETA-2 MICROGLOBULIN KITK082129HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZERK081827HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUSK081674BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)

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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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