FDA 510(k)

SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT

K-Number: K002564 · 2000-10-26

Decision Date2000-10-26

Product CodeDFH

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT 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 2000-10-26 under 510(k) number K002564. 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 SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT?

SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT is a medical device that received FDA 510(k) clearance on 2000-10-26. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K002564.

When did SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT receive FDA 510(k) clearance?

SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT received FDA 510(k) clearance on 2000-10-26, under 510(k) number K002564.

Who is the listed applicant for SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT?

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 SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT?

The FDA product code for SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT is DFH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing The Binding Site, Ltd. as applicant

K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit K090920HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)K083289HUMAN BETA-2 MICROGLOBULIN KIT K082129HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER K081827HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS K081674BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)

View all 115 devices →

Related Devices (Code: DFH)

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 2Sebia K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2Sebia K211648Diazyme 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.