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FDA 510(k)

MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT

K-Number: K024195 · 2003-01-03

ApplicantCorgenix, Inc.
Decision Date2003-01-03
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Corgenix, Inc.. It received FDA 510(k) clearance on 2003-01-03 under 510(k) number K024195. 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 MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT?

MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT is a medical device that received FDA 510(k) clearance on 2003-01-03. The listed applicant is Corgenix, Inc.. The 510(k) number is K024195.

When did MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT receive FDA 510(k) clearance?

MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT received FDA 510(k) clearance on 2003-01-03, under 510(k) number K024195.

Who is the listed applicant for MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT?

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

What is the FDA product code for MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT?

The FDA product code for MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT is MID.

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Other records listing Corgenix, Inc. as applicant

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K072032IGG ANTI-ATHEROX TEST KITK062025ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136K042680RHIGENE HEP-ANA TEST SYSTEMK032139REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826K034013REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001K032868REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139

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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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