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FDA 510(k)

ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT

K-Number: K983694 · 1999-02-05

ApplicantThe Binding Site, Ltd.
Decision Date1999-02-05
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST 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 1999-02-05 under 510(k) number K983694. The device is classified under product code MID. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT?

ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT is a medical device that received FDA 510(k) clearance on 1999-02-05. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K983694.

When did ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT receive FDA 510(k) clearance?

ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT received FDA 510(k) clearance on 1999-02-05, under 510(k) number K983694.

Who is the listed applicant for ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST 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 ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT?

The FDA product code for ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT is MID.

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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: MID)

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.

K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYPhadia US, Inc.K130528BIOPLEX 2200 APLS IGMBio-Rad LaboratoriesK120817QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGAInova Diagnostics, Inc.K113020IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISASImmco Diagnostics, Inc.K103834BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETSBio-Rad Laboratories

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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