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FDA 510(k)

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT

K-Number: K013080 · 2001-09-28

ApplicantCorgenix, Inc.
Decision Date2001-09-28
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG 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 2001-09-28 under 510(k) number K013080. The device is classified under product code MSV. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT?

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT is a medical device that received FDA 510(k) clearance on 2001-09-28. The listed applicant is Corgenix, Inc.. The 510(k) number is K013080.

When did REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT receive FDA 510(k) clearance?

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT received FDA 510(k) clearance on 2001-09-28, under 510(k) number K013080.

Who is the listed applicant for REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG 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 REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT?

The FDA product code for REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT is MSV.

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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: MSV)

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.

K243979Aptiva APS IgA ReagentInova Diagnostics, Inc.K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayPhadia ABK162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYPhadia US, Inc.K091556HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLSInstrumentation Laboratory COK092757THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCRThera-Test 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.

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