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FDA 510(k)

CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM

K-Number: K091845 · 2010-06-07

ApplicantPhadia US, Inc.
Decision Date2010-06-07
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Phadia US, Inc.. It received FDA 510(k) clearance on 2010-06-07 under 510(k) number K091845. 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 CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM?

CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2010-06-07. The listed applicant is Phadia US, Inc.. The 510(k) number is K091845.

When did CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM receive FDA 510(k) clearance?

CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM received FDA 510(k) clearance on 2010-06-07, under 510(k) number K091845.

Who is the listed applicant for CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM?

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

What is the FDA product code for CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM?

The FDA product code for CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM is MID.

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Other records listing Phadia US, 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.

K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYK122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESK113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLEK112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYK111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTSK102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

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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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