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FDA 510(k)

REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001

K-Number: K031208 · 2003-07-07

ApplicantCorgenix, Inc.
Decision Date2003-07-07
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 is the device name listed in this FDA 510(k) record. The listed applicant is Corgenix, Inc.. It received FDA 510(k) clearance on 2003-07-07 under 510(k) number K031208. 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 IGM ANTI-B2GPI TEST KIT, MODEL 038-001?

REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 is a medical device that received FDA 510(k) clearance on 2003-07-07. The listed applicant is Corgenix, Inc.. The 510(k) number is K031208.

When did REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 receive FDA 510(k) clearance?

REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 received FDA 510(k) clearance on 2003-07-07, under 510(k) number K031208.

Who is the listed applicant for REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001?

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 IGM ANTI-B2GPI TEST KIT, MODEL 038-001?

The FDA product code for REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 is MSV.

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Other records listing Corgenix, Inc. as applicant

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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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