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FDA 510(k)

ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM

K-Number: K003069 · 2000-11-27

ApplicantQuest Intl., Inc.
Decision Date2000-11-27
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Quest Intl., Inc.. It received FDA 510(k) clearance on 2000-11-27 under 510(k) number K003069. 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 ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM?

ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2000-11-27. The listed applicant is Quest Intl., Inc.. The 510(k) number is K003069.

When did ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM receive FDA 510(k) clearance?

ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM received FDA 510(k) clearance on 2000-11-27, under 510(k) number K003069.

Who is the listed applicant for ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM?

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

What is the FDA product code for ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM?

The FDA product code for ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM is MID.

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Other records listing Quest Intl., Inc. 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.

K091260SERAQUEST EBV EA-D IGG TESTK033915MODIFICATION TO SERAQUEST EB VCA IGGK033780MODIFICATION TO SERAQUEST VCA IGMK023593SERAQUEST ANTI-THYROID PEROXIDASE (TPO)K023592SERAQUEST ANTI-THYROGLOBULINK991975SERAQUEST EB NA 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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